Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Phase 3

Completed

• Conditions: Progressive IgA Nephropathy; Proteinuria
• Interventions: Drug: ACTH (Acthar) Gel

• Registration Number: NCT02282930
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Study Start: 2015-03
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2019-06
• Results First Submitted: 2019-06-04
• Results First Submitted QC: 2019-06-04
• Last Update Submitted: 2019-06-04
• Results First Posted: 2019-06-26
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACTH Gel	ACTH (Acthar) Gel	Injected does of 80 units subcutaneously twice weekly for 6 months.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a Complete or Partial Response to Treatment	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects to Develop an Infection	12 months	The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis

Trial Locations

Locations (4)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States