Efficacy and Safety of Atacicept in IgA Nephropathy
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | January 31, 2017 |
| End Date: | July 8, 2020 |
| Contact: | US Medical Information |
| Email: | service@emdgroup.com |
| Phone: | 888-275-7376 |
A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in
patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that
treatment with atacicept will reduce proteinuria compared to placebo.
patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that
treatment with atacicept will reduce proteinuria compared to placebo.
Inclusion Criteria:
- Greater than or equal to (>=)18 years of age
- Biopsy-proven Immunoglobulin (IgA) nephropathy
- Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram
(mg/mg) during screening
- Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or
angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening
Exclusion Criteria:
- Concomitant significant renal disease other than IgA nephropathy
- IgA nephropathy with significant glomerulosclerosis or cortical scarring
- Diagnosis of Henoch-Schonlein purpura
- Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement
criteria
- Serum IgG below 6 grams per liter (g/L)
- Use of cyclophosphamide ever or use of other immunosuppressants or systemic
corticosteroids within 4 months
- Active infection requiring hospitalization or treatment with parenteral
anti-infectives within 4 weeks
- History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB
infection
- History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening
- History of malignancy
- Nursing or pregnancy
- Any condition, including any uncontrolled disease state other than IgA nephropathy
We found this trial at
18
sites
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