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