Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|