Status:
COMPLETED
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Kidney Foundation
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00694863
Start Date
July 1 2008
End Date
December 1 2012
Last Update
January 7 2013
Active Locations (1)
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1
Radboud University
Nijmegen, Netherlands, 6500 HB