Overview

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