| Trial name or title |
Efficacy and safety of atacicept in IgA nephropathy |
| Methods |
Parallel RCT |
| Participants |
Setting: multinational Country: USA, Japan, UK Greater than or equal to 18 years of age; biopsy‐provenIgAN; UPCR ≥ 0.75 and ≤ 6 mg/mg during screening; stable and optimal dose of ACEi and/or ARB at least 8 weeks prior to screening Number: 30 participants planned Mean age ± SD (years): not yet available Sex (M/F): not yet available Exclusion criteria: concomitant significant kidney disease other than IgAN; IgAN with significant glomerulosclerosis or cortical scarring; diagnosis of HSP; failure to meet eGFR and biopsy requirement criteria; serum IgG below 6 g/L; use of CPA ever or use of other immunosuppressants or systemic corticosteroids within 4 months; active infection requiring hospitalisation or treatment with parenteral anti‐infective within 4 weeks; history, or current diagnosis, of active 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 IgAN |
| Interventions |
Treatment group 1
Treatment group 2
Treatment group 2
Control group
|
| Outcomes |
Proportion of subjects with adverse events, adverse events of special interest, serious adverse events, adverse events leading to discontinuation, and adverse events leading to death Percent change from baseline in proteinuria Change from baseline in kidney function |
| Starting date |
January 2017 |
| Contact information |
Study Director: EMD Serono Research & Development Institute, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
US Medical Information
888‐275‐7376
service@emdgroup.com
Merck KGaA Communication Center
49 6151 72 5200
service@merckgroup.com |
| Notes |
Estimated completion date: July 2020
No study results available |
