Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy (ACTHiMeN)

Radboud University Medical Center

Status and phase: Completed; Phase 2

Conditions: Idiopathic Membranous Nephropathy

Treatments: Drug: tetracosactide hexacetaat

Study type: Interventional

Funder types: Other

Identifiers

NCT00694863

2008.1

ABR: NL22482.091.08

CMO: 2008/77

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Description:

In this open-label study all patients included are treated in the experimental group.

Treatment:

Drug: tetracosactide hexacetaat