assignment
Not Recruiting

Efficacy and Safety Evaluation of Atacicept in Adult Patients with IgA Nephropathy: A Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled Study

Trial ID
2023-503772-24-00
Protocol
VT-001-0050

Trial statistics

science
6
test molecules
location_city
34
research sites
public
13
countries
person_search
33
investigators
handshake
5
vendors

Objectives

The primary objective of this study is to evaluate the effect of **atacicept** compared to placebo on the change in proteinuria in adult subjects with IgA Nephropathy (IgAN). Proteinuria is a critical marker of kidney damage and its reduction is clinically significant as it may indicate a slowing of disease progression and potential improvement in renal function.

Secondary objectives include:

  • Evaluating the effect of atacicept on the rate of change in estimated glomerular filtration rate (eGFR), which is a key indicator of kidney function.
  • Assessing the impact of atacicept on serum immunoglobulin levels, complement levels, and serum Gd-IgA1 levels, which are relevant to the pathophysiology of IgAN.
  • Determining the safety and tolerability of atacicept, which is essential for understanding the risk-benefit profile of the treatment.
  • Evaluating the pharmacokinetics (PK) of atacicept in serum to understand its absorption, distribution, metabolism, and excretion.
  • Comparing the effect of atacicept to placebo on the annualized rate of change in eGFR, change in Gd-IgA1, and change in urine albumin to creatinine ratio (UACR) in adult subjects with IgAN.
  • Assessing the effect of atacicept on achieving hematuria resolution and on the time from randomization to the first occurrence of a composite kidney failure endpoint event.
  • Evaluating the proportion of participants achieving desirable proteinuria reduction and the effect on patient-reported outcomes (PROs).

Participants

The clinical trial involves a total of **265 participants** diagnosed with **IgA Nephropathy**. The study population comprises adult males and females aged 18 years and older, with specific age restrictions applicable in certain regions, such as a maximum age limit of 70 years in the Czech Republic. Participants were selected based on their ability to provide informed consent and a confirmed diagnosis of IgA Nephropathy via renal biopsy within the past 10 years. The trial includes individuals who are on a stable regimen of renin-angiotensin system inhibitors (RASi) or those who cannot tolerate RASi but are managed according to standard care practices. Participants are required to have a systolic blood pressure of ≤150 mmHg and a diastolic blood pressure of ≤90 mmHg at screening. The study also considers lifestyle factors, ensuring that female participants are not pregnant or breastfeeding and adhere to effective contraceptive methods if of childbearing potential. The trial population includes both male and female subjects, and it is noted that a vulnerable population is involved in the study. The sponsor has not provided additional information regarding specific lifestyle considerations such as diet or physical activity.

Plans and Procedures

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled** study to evaluate the efficacy and safety of **Atacicept** in subjects with **IgA Nephropathy** (IgAN). The trial is divided into two phases: Phase 2b and Phase 3, with the primary objective of assessing the effect of Atacicept compared to placebo on the change in proteinuria in adult subjects with IgAN. The trial is expected to run until November 2028, with recruitment having started in September 2021. Participants will be involved in the study for a maximum treatment period of 156 weeks, depending on the specific phase and treatment group they are assigned to.

Study visits are structured to ensure comprehensive monitoring and data collection. The inclusion (screening) visit will confirm eligibility based on criteria such as age, diagnosis of IgAN, and stable regimen of RASi (ACEi or ARB). Following randomization, participants will attend regular follow-up visits to assess primary and secondary endpoints, including the urine protein to creatinine ratio (UPCR) at weeks 24 and 36, and the annualized rate of change in eGFR at week 104. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any post-study care is arranged.

Participants may be withdrawn from the study early if they experience adverse events, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial involves the administration of Atacicept via **subcutaneous use** and includes a placebo group for comparison. The study's rigorous design and comprehensive visit schedule aim to provide robust data on the efficacy and safety of Atacicept in treating IgAN.

Treatment

The clinical trial involves the administration of several treatments, including both experimental and non-experimental medications. **Atacicept** is the primary experimental medication under investigation. It is provided as a **solution for injection in a pre-filled syringe** and is administered via **subcutaneous use**. The dosing regimen includes three different concentrations: 25 mg/ml, 75 mg/ml, and 150 mg/ml, with a maximum daily dose of 150 mg/ml. The maximum treatment period for Atacicept is 156 days. The pre-filled syringe is composed of a BD Hypak™ SCF™ Barrel Glass barrel with a staked needle and a BD SCF™ Stopper, ensuring ease of administration. Atacicept is a protein-based therapeutic agent, specifically a TACI-Ig fusion protein, and is designated as an orphan drug for the treatment of IgA Nephropathy (IgAN).

The study also includes a **placebo** for Atacicept, which serves as a comparator to evaluate the efficacy and safety of the experimental treatment. The placebo is administered in a similar pharmaceutical form and route as Atacicept, ensuring blinding and consistency in the study design.

**Losartan** is included as a non-experimental treatment in the trial. It is an angiotensin II receptor blocker (ARB) provided in an oral form. The maximum daily dose of Losartan is 100 mg, with a total maximum dose of 127,400 mg over a treatment period of 182 days. Losartan is used as a standard-of-care therapy for managing hypertension and proteinuria in patients with IgAN.

**Enalapril**, another non-experimental treatment, is an angiotensin-converting enzyme inhibitor (ACEi) also administered orally. The maximum daily dose is 40 mg, with a total maximum dose of 50,960 mg over 182 days. Enalapril serves as an alternative standard-of-care therapy, similar to Losartan, for patients with IgAN.

Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment regimen. The study design incorporates rigorous measures to maintain the integrity of the trial, including randomization and double-blinding, to accurately assess the therapeutic effects of Atacicept compared to placebo and standard-of-care treatments.

Efficacy

The efficacy of Atacicept in the treatment of **IgA Nephropathy (IgAN)** will be assessed through a multi-part, randomized, double-blinded, placebo-controlled clinical trial. The primary efficacy endpoint for Phase 2b is the change in urine protein to creatinine ratio (UPCR) at week 24, while for Phase 3, it is the change in UPCR at week 36. Secondary endpoints include the annualized rate of change in estimated glomerular filtration rate (eGFR) at week 104 for Phase 3.

Measurements of UPCR will be conducted at specified time points, with the primary endpoint being evaluated at week 24 for Phase 2b and week 36 for Phase 3. The secondary endpoint, the annualized rate of change in eGFR, will be assessed at week 104. These parameters will be collected and analyzed using standard laboratory tests and validated scales to ensure accuracy and reliability of the data.

Inclusion and Exclusion Criteria

check_circle

Inclusion Criteria

  • Phase 2b_01. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
  • Phase 2b_02. Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provide written informed consent prior to performing any study assessments. For the Czech Republic an age limit of ≤70 also applies
  • Phase 2b_03. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the Screening Visit
  • Phase 2b_04. Total urine protein excretion > 0.75g per 24-hour or UPCR > 0.75 mg/mg based on a 24-hour urine sample during the Screening Period
  • Phase 2b_05. eGFR ≥ 30 mL/min/1.73 m2 at screening as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • Phase 2b_06. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at screening. • The subject is eligible if they do not tolerate RAASi, provided their management of IgAN is SoC according to local guidelines. This must be documented by the Investigator.
  • Phase 2b_07. Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg at screening
  • Phase 2b_08. A female is eligible if she is not pregnant (i.e., after a confirmed menstrual period, a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1), not breastfeeding (for at least 3 months prior to screening), and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP). OR • Is a WOCBP who agrees to use a highly effective contraceptive method (i.e., has a failure rate of less than 1% per year), as listed in Appendix 2, at least 7 days prior to randomization through 175 days after the last dose of study drug. See Appendix 2 for further details.
  • Phase 3_01. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
  • Phase 3_02. Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provide written informed consent prior to performing any study assessments
  • Phase 3_03. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the Screening Visit
  • Phase 3_04. Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
  • Phase 3_05. eGFR ≥ 30 mL/min/1.73 m2 at screening as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • Phase 3_06. On a stable prescribed regimen of RASi (ACEi or ARB) for at least 12 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1 • The subject is eligible if they do not tolerate RASi, provided their management of IgAN is standard of care (SoC) per local practice. This intolerance must be documented by the Investigator and discussed with the Medical Monitor.
  • Phase 3_07. Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg at screening
  • Phase 3_08. A female is eligible if she is not pregnant (i.e., after a confirmed menstrual period, a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1), not breastfeeding (for at least 3 months prior to screening), and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP). OR • Is a WOCBP who agrees to use a highly effective contraceptive method (i.e., has a failure rate of less than 1% per year), as listed in Appendix 2, at least 7 days prior to randomization through 175 days after the last dose of study drug. See Appendix 2 for further details.
cancel

Exclusion Criteria

  • Phase 2b_01. IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), SLE, dermatitis herpetiformis, ankylosing spondylitis
  • Phase 2b_18. History of malignancy (hematologic or solid tumor) within 5 years prior to Screening Visit, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix. *For Germany only the following criteria apply: History of malignancy within the past 5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence).
  • Phase 2b_19. Known hypersensitivity to atacicept or any component of the formulated atacicept
  • Phase 2b_02. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening
  • Phase 2b_20. Major surgery within 6 weeks prior to the Screening Visit or planned/expected major surgery during the study period
  • Phase 2b_21. Clinically significant history of alcohol or drug abuse in the 1 year prior to the Screening Visit as per Investigator opinion
  • Phase 2b_22. Unwillingness or lack of capacity to follow all study procedures
  • Phase 2b_23. Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to the Screening Visit.
  • Phase 2b_03. Evidence of nephrotic syndrome within 6 months of screening (serum albumin < 30g/L in association with UPCR >3.5 mg/mg
  • Phase 2b_04. Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during Screening
  • Phase 2b_05. Renal or other organ transplantation prior to, or expected during, the study with the exception of corneal transplants
  • Phase 2b_10. Clinically significant or predefined abnormalities per central laboratory tests, at the Screening Visit, meeting any of the criteria below: • serum IgG below 7 g/L • aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level > 2.5 × upper limit of normal (ULN) or total bilirubin >1.5 x ULN. i. If subject has a known history of Gilberts (history of isolated increase in total bilirubin without increase in liver transaminases), contact the Medical Monitor for further discussion. • For The Czech Republic only, the following criteria also apply: - hemoglobin <10 g/100 mL in men and hemoglobin <9 g/100 mL in women - platelets <100,000/mm3
  • Phase 2b_06. Concomitant chronic renal disease in addition to IgAN (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis (FSGS), membranous nephropathy, C3 glomerulopathy, lupus nephritis)
  • Phase 2b_07. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
  • Phase 2b_08. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test at the Screening Visit.
  • Phase 2b_09. Prohibited medications: • Use of systemic corticosteroids or immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for the treatment of IgAN within 3 months prior to screening or expected use during the study. • For non-IgAN indications (e.g., gout flare, exacerbation of asthma, severe rash, etc): • Within 3 months prior to randomization: Use of systemic corticosteroids or immunosuppressive medications for > 1 week or 0.5 mg/kg/day prednisolone or equivalent • Use of B-cell–directed biologic therapies including blisibimod, belimumab, rituximab, ocrelizumab for any period of time • Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics
  • Phase 3_01. Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept.
  • Phase 3_02. IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
  • Phase 3_03. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
  • Phase 3_04. Total urine protein excretion ≥5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥5 mg/mg based on a 24-hour urine sample during the Screening Period
  • Phase 3_05. Evidence of nephrotic syndrome within 6 months of screening (serum albumin <3.0 g/dL in association with UPCR >3.5 mg/mg)
  • Phase 3_06. Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants
  • Phase 2b_11. Administration of live and live-attenuated vaccinations within 30 days prior to randomization
  • Phase 3_07. Concomitant chronic renal disease in addition to IgAN (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis (FSGS), membranous nephropathy, C3 glomerulopathy, lupus nephritis)
  • Phase 2b_12. History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
  • Phase 2b_13. Patients with history of unstable angina, Class III and IV congestive heart failure and/or clinically significant arrhythmia, as judged by the Investigator.
  • Phase 2b_14. Any condition, including any uncontrolled disease state other than IgAN, that in the opinion of the Investigator or the Sponsor/designee constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
  • Phase 2b_15. Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to, or during the Screening Visit, or completion of oral anti-infectives within 2 weeks prior to, or during the Screening Visit or a history of recurrent infections (i.e., 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary. *For Germany only, the following criteria also apply: Specifically for COVID-19: Evidence of positive test for SARS-CoV-2, by PCR, at the Screening Visit; Subjects with a previous COVID-19 infection may be included provided the PCR test is negative for SARS-CoV-2 and they do not have chronic symptoms as a result of COVID-19. COVID-19 testing may be performed at local lab, per site/local guidelines.
  • Phase 2b_16. History of acute or chronic infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. Positive hepatitis B surface antigen (HBsAg): Subjects who are HBsAg negative and hepatitis B core antibody (HBcAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring through safety follow-up.
  • Phase 2b_17. History of splenectomy
  • Phase 3_08. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
  • Phase 3_09. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test at the Screening Visit. If the subject is undergoing current treatment for LTBI, they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to the Screening Visit without evidence of re-exposure to be eligible for this study. If on LTBI treatment at the Screening Visit, the subject will be expected to complete an appropriate LTBI treatment regimen to remain in the trial. • Subjects with current household contacts with active TB will be excluded unless prophylaxis treatment has been completed, and evidence that household contacts have completed treatment is provided. • Indeterminate Quantiferon tests may be repeated once by the same test and will be considered positive if retest results are positive or indeterminate.
  • Phase 3_10. Prohibited medications: • Use of systemic corticosteroids (including oral budesonide) for the treatment of IgAN within 6 months prior to screening, from screening to Day 1 or expected use during the study. - For glucocorticosteroids (GCS), “Systemic” is defined as oral, rectal or injectable (intravenous or intramuscular) routes of administration. Other routes of administration are allowed, including intra-articular, inhaled, topical, ophthalmic, otic and intranasal. • For non-IgAN indications (e.g., gout flare, exacerbation of asthma, severe rash, etc.): - Within 12 weeks prior to randomization: Use of systemic corticosteroids or immunosuppressive medications for >1 week or average dose >0.5 mg/kg/day prednisolone or equivalent • Immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for the treatment of IgAN within 12 weeks prior to screening, from screening to Day 1 or expected use during the study. • Use of traditional Chinese medications and/or Ayurvedic medications for IgAN within 12 weeks prior to screening, from screening to Day 1, or during the study period. - Including but not limited to: Lei Gong Teng, Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum. Any other medications used to treat IgAN that are not listed should be discussed with the Medical Monitor. • Use of B-cell–directed biologic therapies including but not limited to belimumab, rituximab, ocrelizumab for any period of time • Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics for any period of time • Use of endothelin receptor antagonists (ERAs) for any period of time • Use of complement inhibitors including but not limited to iptacopan for any period of time
  • Phase 3_11. Clinically significant or predefined abnormalities per central laboratory tests, at the Screening Visit, meeting any of the criteria below: • serum IgG below 7 g/L • aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level > 2.5 × upper limit of normal (ULN) or total bilirubin >1.5 x ULN. i. If subject has a known history of Gilberts (history of isolated increase in total bilirubin without increase in liver transaminases), contact the Medical Monitor for further discussion. • hemoglobin <10 g/100 mL in men and hemoglobin <9 g/100 mL in women • platelets <100 10^9/L
  • Phase 3_12. Administration of live and live-attenuated vaccinations within 30 days prior to randomization
  • Phase 3_13. History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
  • Phase 3_14. Patients with history of unstable angina, Class III and IV congestive heart failure and/or clinically significant arrhythmia, as judged by the Investigator.
  • Phase 3_15. Any condition, including any uncontrolled disease state other than IgAN, that in the opinion of the Investigator or the Sponsor/designee constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
  • Phase 3_16. Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to, or during the Screening Visit, or completion of oral anti-infectives within 2 weeks prior to, or during the Screening Visit or a history of recurrent infections (i.e., 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary. Specifically for COVID-19: Evidence of positive test for SARS-CoV-2, by PCR, at the Screening Visit; Subjects with a previous COVID-19 infection may be included provided the PCR test is negative for SARS-CoV-2 and they do not have chronic symptoms as a result of COVID-19. COVID-19 testing may be performed at local lab, per site/local guidelines.
  • Phase 3_17. History of acute or chronic infection with human immunodeficiency virus, or hepatitis B virus. • Positive hepatitis B surface antigen (HBsAg) are excluded • Subjects who are HBsAg negative, hepatitis B core antibody (HBcAb) positive, hepatitis B surface antibody (HBsAb) positive, and with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring through safety follow-up
  • Phase 3_18. Subjects with positive hepatitis C (HCV) RNA are excluded, however, subjects who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
  • Phase 3_19. History of splenectomy
  • Phase 3_20. History of malignancy within the past 5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence).
  • Phase 3_21. Known hypersensitivity to atacicept or any component of the formulated atacicept
  • Phase 3_22. Major surgery within 6 weeks prior to the Screening Visit or planned/expected major surgery during the study period (including the Safety FU Period) • Major surgery often involves opening one of the major body cavities (abdomen, chest, and skull) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (for example, hip replacement)
  • Phase 3_23. Clinically significant history of alcohol or drug abuse in the 1 year prior to the Screening Visit as per Investigator opinion
  • Phase 3_24. Unwillingness or lack of capacity to follow all study procedures
  • Phase 3_25. Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to the Screening Visit.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Belgium BelgiumNot Recruiting15 Sept 202122
Croatia CroatiaNot Recruiting15 Sept 20218
Czechia CzechiaNot Recruiting15 Sept 202113
Denmark DenmarkNot Recruiting15 Sept 202120
Estonia EstoniaNot Recruiting15 Sept 202110
France FranceNot Recruiting15 Sept 202132
Germany GermanyNot Recruiting15 Sept 202113
Greece GreeceNot Recruiting15 Sept 202124
Ireland IrelandNot Recruiting15 Sept 20218
Italy ItalyNot Recruiting15 Sept 202121
1–10 of 13
1 / 2

Sites & Investigators

Investigational Products

Details about the medicinal products being studied in this clinical trial.

Product Name Role in Trial Formulation Administration Max Daily Dose Treatment Duration EU MP Number
Atacicept
TestSOLUTION FOR INJECTION IN PRE-FILLED SYRINGESUBCUTANEOUS USE2536PRD10245859
Atacicept
TestSOLUTION FOR INJECTION IN PRE-FILLED SYRINGESUBCUTANEOUS USE150156PRD10245858
Placebo of Atacicept
PlaceboN/AN/A
Atacicept
TestSOLUTION FOR INJECTION IN PRE-FILLED SYRINGESUBCUTANEOUS USE7536PRD10245860
LOSARTAN
OtherPHF00082MIGORAL USE100182SCP138833
ENALAPRIL
OtherPHF00245MIGORAL USE40182SCP135534

Interventions Studied in This Trial

vaccines
Enalapril
2 trials

Also investigated for

vaccines
Losartan
3 trials