Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Dutch Kidney Foundation
• Treatments: Adrenocorticotropic Hormone; Adrenocorticotropin zinc; Cosyntropin

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