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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00805753
Other study ID # 08-006328
Secondary ID
Status Completed
Phase Phase 1
First received December 9, 2008
Last updated October 10, 2014
Start date January 2009
Est. completion date September 2014

Study information

Verified date October 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ACTH
comparison of different dosages of drug

Locations

Country Name City State
Canada University of Toronto Toronto Ontario
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Mallinckrodt

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in proteinuria baseline, 3 months No
Primary Change in LDL cholesterol, HDL cholesterol, and triglycerides baseline, 3 months No
Primary Change in side effects/toxicity baseline, 3 months Yes
Secondary Number of subjects with CR or PR 3 months No
Secondary The effect of maximizing angiotensin II blockade on proteinuria 3 months No
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