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

NCT01028287 | Completed Phase 4

• 1 other identifier: ACTH-NRDN
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathy; Nephrotic Syndrome

Keywords

Diabetic Nephropathy; Nephrotic syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving less than 300 mg protein per 24 hours after 6 months of Acthar Gel.

  6 months

Secondary Outcomes (1)

• Percentage of patients achieving greater than 50% reduction in urinary proteinuria after 6 months of Acthar Gel.

  6 months

Study Arms (2)

ACTH-16 units

ACTIVE COMPARATOR

Patients with nephrotic range proteinuria randomized to this group will receive 16 units ACTHargel sub-cutaneously every day.

Drug: ACTH

ACTH-32 units

ACTIVE COMPARATOR

Patients with nephrotic range proteinuria randomized to this group will receive 32 units ACTHargel sub-cutaneously every day.

Drug: ACTH

Interventions

ACTH DRUG

Patients with nephrotic range proteinuria randomized to this group will receive 16 units ACTHargel sub-cutaneously every day.

Also known as: ACTHar Gel

ACTH-16 units; ACTH-32 units

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Southeast Renal Research Institute: lead
• Mallinckrodt: collaborator

Study Sites (1)

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

Location

Related Publications (1)

• Tumlin JA, Galphin CM, Rovin BH. Advanced diabetic nephropathy with nephrotic range proteinuria: a pilot study of the long-term efficacy of subcutaneous ACTH gel on proteinuria, progression of CKD, and urinary levels of VEGF and MCP-1. J Diabetes Res. 2013;2013:489869. doi: 10.1155/2013/489869. Epub 2013 Sep 12.

  PMID: 24159603 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Nephrotic Syndrome

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Nephrosis

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• James A. Tumlin, MD

  Southeast Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2011
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (1)