Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
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.