Controlled clinical trial to evaluate the clinical efficacy and safety of a drug that inhibits renin, aliskiren, compared to an angiotensin converting enzyme inhibitor enalapril in children and adults with the kidney disease C3 glomerulopathy

Phase 1

• Conditions: C3 glomerulopathy; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001440-22-SE
• Lead Sponsor: Skåne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-21
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Children = 6 years and adults.
2. Initial diagnosis of Dense Deposit Disease and C3 glomerulonephritis confirmed by kidney biopsy obtained not more than 2 years before the first dose of the study drug.
3. Either absence of treatment at the study start or ongoing treatment with aliskiren, ACEi, ARBs or immune suppressive medications (such as mycophenolate mofetil/MMF or corticosteroids)
4. Written informed consent has been given by:
a. the patient’s legal guardians if the patient is less than 15 years old
b. the patient and his/her legal guardians if the patient is = 15 but < 18years old
c. the patient if the patient is = 18 years old

5. Female subjects of childbearing potential must:
a. Understand that the study medication is expected to have a teratogenic risk
b. Agree to use a highly effective contraception during study drug therapy. This applies unless the subject is less than 18 years of age, has not had sexual debut and commits to sexual abstinence confirmed by a pregnancy test on every study visit.
c. Agree to have a pregnancy test before the start of study medication. This requirement also applies to women of childbearing age who practice complete and continued abstinence and adolescent girls after menarche.
d. Agree to have a pregnancy test every 3rd month including at the end of study treatment, except in the case of confirmed tubal sterilization. This requirement also applies to women of childbearing age who practice complete and continued abstinence and adolescent girls after menarche.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Known allergy to aliskiren or enalapril or substances contained in these preparations.

2. Angioedema caused by aliskiren or enalapril

3. Weight < 25 kg.

4. Glomerular filtration rate = 50 ml/min/1.73 m2 (measured by iohexol clearance) in children and = 30 ml/min/1.73 m2 in adults.

5. Rapid deterioration of kidney function during the latest year of the disease

5. Patients with a renal transplant.

6. Immune complex-mediated membranoproliferative glomerulonephritis (such as in HIV infection, hepatitis, SLE).

7. Females who breastfeed, are pregnant or planning to become pregnant during the study.

8. Co-morbidity such as malignancy, congestive heart failure, recent myocardial infarction.

9. Mental incapacity or language barriers to understand the contents of the study design.

10. Simultaneous use of another complement-antagonist (such as eculizumab). Eculizumab must be discontinued and complement activity normalized before the start of study drug.

11. Simultaneous use of aliskiren or enalapril with cyclosporine or nonsteroidal anti-inflammatory drugs (NSAID).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified