Membranous nephropathy MedDRA version: 9.1 Level: LLT Classification code 10027170 Term: Membranous nephropathy
Conditions
Interventions
Trade Name: Synacthen Depot 1mg
Pharmaceutical Form: Suspension for injection
Sponsors
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-75 years - Biopsy-proven idiopathic membranous nephropathy. - Nephrotic syndrome: proteinuria > 3.5 g/day and serum albumine 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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. | — |
Countries
Netherlands
Outcome results
None listed