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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00805753 |
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Date of registration:
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09/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy
MN |
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Scientific title:
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A Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN) |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00805753 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Fernando C Fervenza, M.D., Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Membranous Nephropathy
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Intervention(s)
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Drug: ACTH
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Primary Outcome(s)
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Change in proteinuria
[Time Frame: baseline, 3 months]
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Change in side effects/toxicity
[Time Frame: baseline, 3 months]
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Change in LDL cholesterol, HDL cholesterol, and triglycerides
[Time Frame: baseline, 3 months]
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Secondary Outcome(s)
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Number of subjects with CR or PR
[Time Frame: 3 months]
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The effect of maximizing angiotensin II blockade on proteinuria
[Time Frame: 3 months]
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Secondary ID(s)
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08-006328
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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