Treatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMeN

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001647-19-NL
• Date of registration: 04/06/2008
• Prospective Registration: No
• Primary sponsor: Radboud University Nijmegen Medical Center
• Public title: Treatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMeN
• Scientific title: Treatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMeN
• Date of first enrolment: 22/05/2008
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001647-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
- Age 18-75 years
- 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, eGFR by
MDRD formula)
- High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
- Relative contra-indication for cyclophosphamide treatment :
a. fertility and wish for (future) family expanding
b. high age ( > 60 years)
c. former cyclophosphamide treatment
d. intolerance to cyclophosphamide

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Clinical, biochemical or histological signs of any underlying systemic
disease.
- Any infectious disease (including latent tuberculosis and/or latente
amoebiasis)
- Active gastic or duodenal ulcers
- Pregnancy, lactation, inadequate contraceptives
- Clinical signs of renal vein thrombosis
- Astma and /or any allergic conditions or hypersensitivity reactions
- Allergic reaction to synthetic ACTH in the past



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Membranous nephropathy
MedDRA version: 9.1 Level: LLT Classification code 10027170 Term: Membranous nephropathy

Intervention(s)

Trade Name: Synacthen Depot 1mg
Pharmaceutical Form: Suspension for injection

Primary Outcome(s)

Secondary Objective: - To study the efficacy of ACTH therapy in patients with membranous nephropathy.
- To study the safety of ACTH therapy in patients with membranous nephropathy.
- To study the acting mechanism of ACTH therapy in patients with membranous nephropathy by studying the effect of ACTH treatment to endogenous cortisol/cortison production.

Main Objective: To study ACTH therapy as an alternative to alkylating agents in the treatment of patients with membranous nephropathy, a nephrotic syndrome and high risk for renal failure.

The main objective of the trial is to study if patients can complete the treatment with intramuscular injections twice a week for a period of nine months.

Primary end point(s): Attainability of ACTH therapy with intramuscular injections twice a week for a period of nine months, measured as the percentage of injections that has been received in line with the treatment schedule.

Secondary ID(s)

2008.1