Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure
Information source: Radboud University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Membranous Nephropathy
Intervention: tetracosactide hexacetaat (Drug)
Phase: Phase 2
Status: Not yet recruiting
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
Overall contact:
Julia M Hofstra, M.D., Phone: +31 24 3614761, Email: J.Hofstra@nier.umcn.nl
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: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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: 75 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 :
1. fertility and wish for (future) family expanding
2. high age ( > 60 years)
3. former cyclophosphamide treatment
4. 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
Julia M Hofstra, M.D., Phone: +31 24 3614761, Email: J.Hofstra@nier.umcn.nl
Radboud University, Nijmegen 6500 HB, Netherlands
Additional Information
Starting date: July 2008
Ending date: July 2012
Last updated: June 10, 2008
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