Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression
|ClinicalTrials.gov Identifier: NCT02282930|
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Progressive IgA Nephropathy Proteinuria||Drug: ACTH (Acthar) Gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: ACTH Gel
Injected does of 80 units subcutaneously twice weekly for 6 months.
Drug: ACTH (Acthar) Gel
Injected dose of 80 units subcutaneously twice weekly for 6 months.
- Achieving Complete or Partial Response [ Time Frame: 12 Months ]
<300 mg proteinuria/24 hours No greater than a 10% reduction in GFR as determined by quantified creatinine clearance.
>50% reduction in 24 hour proteinuria No greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
A < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels will be considered no response.
A greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
- Exploratory (Improvement in hematuria) [ Time Frame: 12 Months ]Improvement in hematuria. Categorical: <3 rbc/hpf; up to 20 rbc/hpf; 20 to 50; 50 to 100; >100 rbc/hpf
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282930
|United States, California|
|Palo Alto, California, United States, 94304|
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Fernando Fervenza, MD, PhD||Mayo Clinic|