Treatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMe

• Conditions: Membranous nephropathy; MedDRA version: 9.1Level: LLTClassification code 10027170Term: Membranous nephropathy

• Registration Number: EUCTR2008-001647-19-NL
• Lead Sponsor: Radboud University Nijmegen Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Age 18-75 years
-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, eGFR by
MDRD formula)
-High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
-Relative contra-indication for cyclophosphamide treatment :
a.fertility and wish for (future) family expanding
b.high age ( > 60 years)
c.former cyclophosphamide treatment
d.intolerance to cyclophosphamide

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Clinical, biochemical or histological signs of any underlying systemic
disease.
-Any infectious disease (including latent tuberculosis and/or latente
amoebiasis)
-Active gastic or duodenal ulcers
-Pregnancy, lactation, inadequate contraceptives
-Clinical signs of renal vein thrombosis
-Astma and /or any allergic conditions or hypersensitivity reactions
-Allergic reaction to synthetic ACTH in the past

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study ACTH therapy as an alternative to alkylating agents in the treatment of patients with membranous nephropathy, a nephrotic syndrome and high risk for renal failure. <br><br>The main objective of the trial is to study if patients can complete the treatment with intramuscular injections twice a week for a period of nine months.;Secondary Objective: - To study the efficacy of ACTH therapy in patients with membranous nephropathy. <br>- To study the safety of ACTH therapy in patients with membranous nephropathy. <br>- To study the acting mechanism of ACTH therapy in patients with membranous nephropathy by studying the effect of ACTH treatment to endogenous cortisol/cortison production.<br>;Primary end point(s): Attainability of ACTH therapy with intramuscular injections twice a week for a period of nine months, measured as the percentage of injections that has been received in line with the treatment schedule.