Dose-Finding Pilot Study of ACTH in Patients With Idiopathic 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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-09-30

Brief Summary

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This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.

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Detailed Description

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Conditions

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Idiopathic Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 ACTH 40 units

Receive ACTH at the dose of 40 units sub-cutaneously for up to 12 weeks. If at day 91 no response has been shown, you will have the option to increase the dose of ACTH to 80 units for up to an additional 120 days.

Group Type ACTIVE_COMPARATOR

ACTH

Intervention Type DRUG

comparison of different dosages of drug

Arm 2 ACTH 80 units

Receive ACTH at the dose of 80 units sub-cutaneously for up to 12 weeks.

Group Type ACTIVE_COMPARATOR

ACTH

Intervention Type DRUG

comparison of different dosages of drug

Interventions

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ACTH

comparison of different dosages of drug

Intervention Type DRUG

Other Intervention Names

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H.P. Acthar Gel

Eligibility Criteria

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Inclusion Criteria

1. Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization.
2. Age \> 18 years.
3. Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to ACTH treatment and have adequately controlled blood pressure
4. Proteinuria of \>4.0 on a 24-hour urine collection.
5. Estimated GFR \>40 ml/min/1.73m2 while taking ACEI/ARB therapy.

Exclusion Criteria

1. Age \<18 years.
2. Estimated GFR \<40 ml/min/1.73m2, or serum creatinine \>2.0 mg/dl.
3. Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
4. Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for \>1 month, and alkylating agents or rituximab for \>6 months.
5. Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids.
6. Patients with active infections or secondary causes of MN.
7. Type 1 or 2 diabetes mellitus.
8. Pregnancy or nursing.
9. Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No