Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy

NCT01093157

Glomerulonephritis

COMPLETED PHASE1/PHASE2

Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes

NCT01021540

Nephrotic Syndromes

COMPLETED PHASE4

Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome

NCT03298698

Idiopathic Nephrotic Syndrome Minimal Change Disease Focal Segmental Glomerulosclerosis

UNKNOWN PHASE3

Treatment of Patients With Idiopathic Membranous Nephropathy

NCT00135954

Glomerulonephritis, Membranous

COMPLETED PHASE3

ACTH Treatment of APOL1- Associated Nephropathy

NCT02006849

Kidney Disease

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Membranous Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

tetracosactide hexacetaat

Intervention Type DRUG

Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tetracosactide hexacetaat

Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Synacthen Depot, long-acting synthetic ACTH

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No