A Clinical Trial to Examine the Effects of the Drug Atacicept in Patients with Nephropathy (Diabetic Kidney Disease).

Phase 1

• Conditions: IgA Nephropathy; MedDRA version: 20.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2016-002262-31-GB
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-27
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

For inclusion in the study, all of the following inclusion criteria must be fulfilled:
1. =18 years of age
2. Biopsy-proven IgA nephropathy
3. Proteinuria 1 to 6 g/day
4. Stable and optimal dose of ACE inhibitor and/or ARB at least 8 weeks prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Concomitant significant renal disease other than IgA nephropathy
2. IgA nephropathy with significant glomerulosclerosis or cortical scarring
3. Diagnosis of Henoch-Schonlein purpura
4. Meets eGFR and biopsy requirement criteria
5. Serum IgG below 6 g/L
6. Use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months
7. Active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks
8. History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection
9. History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening
10. History of malignancy
11. Nursing or pregnancy
12. Any condition, including any uncontrolled disease state other than IgA nephropathy.

Study & Design

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