Ignite Creation Date:
2024-05-06 @ 12:34 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01601236
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2012-05-15
Brief Title:
Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Adaptive Design Pilot Safety and Efficacy Study of HP Acthar Gel Acthar in Patients With Diabetic Nephropathy and Proteinuria
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 01 mL 16 U 02 mL and 32 U 04 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None