Safety and Efficacy of Combination Acthar Gel and Tacrolimus in the Treatment of Steroid Resistant Nephrotic Syndrome
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|ClinicalTrials.gov Identifier: NCT03042637|
Recruitment Status : Unknown
Verified February 2017 by James A. Tumlin MD, Southeast Renal Research Institute.
Recruitment status was: Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment|
|Nephrotic Syndrome||Drug: Acthar Gel and Tacrolimus|
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Safety and Efficacy of Combination Acthar Gel and Tacrolimus in the Treatment of Steroid Resistant Nephrotic Syndrome|
|Actual Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Acthar Gel and Tacrolimus
Combination therapy with Acthar Gel and Tacrolimus
Drug: Acthar Gel and Tacrolimus
Combination therapy with Acthar Gel and Tacrolimus (0.5-3.0 mg BID) following 6 months of ACTH therapy only
- Reduction of proteinuria in idiopathic membranous glomerulonephritis (MGN) and other forms of glomerulopathy including focal segmental glomerulosclerosis (FSGS) and advanced diabetic nephropathy [ Time Frame: 6 months ]Subjects with steroid resistant nephrotic syndrome were treated with sub-cutaneous (SQ) ACTHar gel, (40-80 units) SQ 2X-3X/week. After 6 months of ACTHar gel therapy subjects achieving complete remission were weaned off therapy over a 3-12 month period.
- Partial remission or no response to treatment regiment [ Time Frame: 6 months ]Subjects exhibiting no response or partial remission were maintained on existing ACTHar gel doses and started on oral Tacrolimus (0.03 to 0.06 mg/kg/day) titrating to a trough level of 5-10 ng/ml for an additional 6 months.
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): NCT03042637
|United States, Tennessee|
|Southeast Renal Research Institute|
|Chattanooga, Tennessee, United States, 37408|
|Principal Investigator:||James A Tumlin, MD||NephroNet Clinical Research Consortium|