Overview

Adrenocorticotropic Hormone (ACTH) Treatment of Nephrotic Range Proteinuria in Diabetic Nephropathy (NRDN)

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is a prospective open labeled trial examining the efficacy of ACTHar Gel (porcine ACTH) on the level of proteinuria in patients with diabetic nephropathy and nephrotic range proteinuria.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southeast Renal Research Institute
Collaborator:
Mallinckrodt
Treatments:
Adrenocorticotropic Hormone
beta-Endorphin
Melanocyte-Stimulating Hormones
Criteria
Inclusion Criteria:

1. Age > 18 and < 80

2. Type I or Type II Diabetes Mellitus

3. Stable ACE or ARB therapy for 4 weeks prior to study enrollment

4. Urinary protein > 3000 mg/24 hrs

5. Patients with more than one protein lowering agent (e.g. ACE or ARB, or MR antagonist
or Tekturna require two consecutive 24 hour urinary protein of 2000 mg/24 hrs.

Exclusion Criteria:

1. Age <18 or >80

2. HgbA1c > 9.0% or 11% if using the (DCCT / NGSP) method.

3. eGFR < 20 mls/min by MDRD formula or eGFR by (Cockoff-Gault 20 mls/min)

4. Dilated cardiomyopathy with known EF < 40%

5. Pregnant or nursing mothers

6. Patients with an admission for diabetic ketoacidosis, or non-ketotic hyperosmolar coma
within 6 months of study enrollment.

7. Patients with known mixed glomerulonephritis and diabetic glomerulopathy

8. Patients within 3 mths of operative procedures or chronic non-healing wounds

9. Patients with glucocorticoid-induced diabetes mellitus

10. Patients with known sensitivity to porcine protein products

11. Patients with bleeding gastric or duodenal ulcers requiring hospitalization six months
prior to study enrollment