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Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Membranous Nephropathy

Intervention: tetracosactide hexacetaat (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
Jack FM Wetzels, M.D.Ph.D., Study Director, Affiliation: Department of Nephrology, Radboud University
Julia M Hofstra, M.D., Principal Investigator, Affiliation: Department of Nephrology, Radboud University

Summary

The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.

Clinical Details

Official title: Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.

Secondary outcome: Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment

Eligibility

Minimum age: 18 Years. Maximum age: 95 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Biopsy-proven idiopathic membranous nephropathy.

- Nephrotic syndrome: proteinuria > 3. 5 g/day and serum albumine < 30 g/l

- Normal or mildly impaired renal function (eGFR > 60 ml/min, MDRD formula)

- High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min

- Relative contra-indication for cyclophosphamide treatment:

- fertility and wish for (future) family expanding

- high age ( > 60 years)

- former cyclophosphamide treatment

- intolerance to cyclophosphamide

Exclusion Criteria:

- Clinical,biochemical or histological signs of any underlying systemic disease

- Any infectious disease (including latent tuberculosis and/or latent amoebiasis)

- Active gastric or duodenal ulcers

- Pregnancy, lactation, inadequate contraceptives

- Clinical signs of renal vein thrombosis

- Asthma and /or any allergic conditions or hypersensitivity reactions

- Allergic reaction to synthetic ACTH in the past

Locations and Contacts

Radboud University, Nijmegen 6500 HB, Netherlands
Additional Information

Starting date: July 2008
Last updated: January 4, 2013

Page last updated: August 23, 2015

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