Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients

Status Completed

Clinical Trial Summary

This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety of daily Acthar administration in diabetic patients with nephropathy and proteinuria. Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be enrolled and randomized into 6 study groups and will be treated with either Acthar or Placebo for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The study will compare three dose regimens of Acthar (8 U [0.1 mL], 16 U [0.2 mL], and 32 U [0.4 mL]) to equivalent volumes of Placebo to ensure the double-blind nature of the study.

Insulin-requiring patients are being enrolled to aid compliance with the daily SC administration of study medication and to allow for ease of blood glucose control by adjustment of current insulin therapy in the event of glycemic excursions. Routine safety measures, including glycemic control, will be monitored throughout the study. The adaptive design component of the study allows for the re-assignment of the high dose group to the mid dose group if unacceptable toxicity is noted as per study protocol in the high dose group. Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria (via urinary protein to creatinine ratio [PCR]). Serum cortisol concentration and additional biomarkers in blood and urine will also be monitored.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01601236
Study type	Interventional
Source	Mallinckrodt
Contact
Status	Completed
Phase	Phase 2
Start date	May 2012
Completion date	March 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04562025` - Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy	N/A
Not yet recruiting	`NCT03658317` - Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy	N/A
Recruiting	`NCT02501772` - The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy	N/A
Completed	`NCT02251067` - Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients	Phase 2
Completed	`NCT02276196` - Effect of LIXIsenatide on the Renal System	Phase 4
Completed	`NCT02829177` - Microalbuminuria and Allopurinol in Type 1 Diabetes	Phase 4
Completed	`NCT01440257` - A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria	Phase 2
Active, not recruiting	`NCT01273675` - An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy	N/A
Terminated	`NCT01129557` - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease	Phase 4
Completed	`NCT00317954` - Spironolactone in Diabetic Nephropathy	Phase 4
Active, not recruiting	`NCT02237352` - Mechanisms of Diabetic Nephropathy in Ecuador
Not yet recruiting	`NCT05061459` - The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy
Completed	`NCT01935167` - To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy	Phase 2
Recruiting	`NCT01673204` - Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy	Phase 4
Completed	`NCT01726816` - Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy	Phase 2
Recruiting	`NCT01458158` - Matrix Metalloproteinases in Atherosclerosis of Chronic Kidney Disease	N/A
Completed	`NCT01447147` - A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy	Phase 2
Completed	`NCT01476501` - Vitamin D Supplementation in Diabetic Nephropathy	Phase 2
Completed	`NCT01003236` - Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy	Phase 2
Completed	`NCT00535925` - Nephropathy In Type 2 Diabetes and Cardio-renal Events	Phase 4