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Completed

NCT Number: NCT00805753

Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy

This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.

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Key information

Conditions

Idiopathic Membranous Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Toronto, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization.
  • Age > 18 years.
  • Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to ACTH treatment and have adequately controlled blood pressure
  • Proteinuria of >4.0 on a 24-hour urine collection.
  • Estimated GFR >40 ml/min/1.73m2 while taking ACEI/ARB therapy.

Exclusion criteria

  • Age <18 years.
  • Estimated GFR <40 ml/min/1.73m2, or serum creatinine >2.0 mg/dl.
  • Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
  • Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for >1 month, and alkylating agents or rituximab for >6 months.
  • Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids.
  • Patients with active infections or secondary causes of MN.
  • Type 1 or 2 diabetes mellitus.
  • Pregnancy or nursing.
  • Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy.

Treatment and study plan

ACTH

Drug

comparison of different dosages of drug

Other names: H.P. Acthar Gel

Primary outcomes

  1. Change in proteinuria

    Time frame: baseline, 3 months

  2. Change in LDL cholesterol, HDL cholesterol, and triglycerides

    Time frame: baseline, 3 months

  3. Change in side effects/toxicity

    Time frame: baseline, 3 months

Secondary outcomes

  1. Number of subjects with CR or PR

    Time frame: 3 months

  2. The effect of maximizing angiotensin II blockade on proteinuria

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

A Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN)

Acronym: MN

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Dec 10, 2008
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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