Pilot Study of ACTH in the Treatment of Immunoglobulin A (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 : Completed
First Posted : November 5, 2014
Results First Posted : June 26, 2019
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Progressive IgA Nephropathy Proteinuria||Drug: ACTH (Acthar) Gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 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|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 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.
- Number of Subjects With a Complete or Partial Response to Treatment [ Time Frame: 12 Months ]
A complete response is defined by <300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance.
A partial response is defined by >50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
No response is defined by < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance.
- Number of Subjects to Develop an Infection [ Time Frame: 12 months ]The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis
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|