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

Completed · Phase 4

Conditions studied: Diabetic Nephropathy, Nephrotic Syndrome

In brief

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.

Key facts

Study ID: NCT01028287
Run by: Southeast Renal Research Institute
People needed: 15
Starts: 2009-05-01
Expected to finish: 2011-07-01
Last updated by the study team: 2013-05-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age > 18 and < 80
Type I or Type II Diabetes Mellitus
Stable ACE or ARB therapy for 4 weeks prior to study enrollment
Urinary protein > 3000 mg/24 hrs
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.

You may not qualify if…

Age <18 or >80
HgbA1c > 9.0% or 11% if using the (DCCT / NGSP) method.
eGFR < 20 mls/min by MDRD formula or eGFR by (Cockoff-Gault 20 mls/min)
Dilated cardiomyopathy with known EF < 40%
Pregnant or nursing mothers
Patients with an admission for diabetic ketoacidosis, or non-ketotic hyperosmolar coma within 6 months of study enrollment.
Patients with known mixed glomerulonephritis and diabetic glomerulopathy
Patients within 3 mths of operative procedures or chronic non-healing wounds
Patients with glucocorticoid-induced diabetes mellitus
Patients with known sensitivity to porcine protein products
Patients with bleeding gastric or duodenal ulcers requiring hospitalization six months prior to study enrollment

Where it is running

Southeast Renal Research Institute — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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