- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001959
Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
Pirfenidone in Focal Segmental Glomerulosclerosis:Phase II Study
This study will examine the effectiveness of the drug pirfenidone in treating focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in the urine). About half of patients with FSGS eventually require kidney dialysis or transplant. Steroids, which are currently used to treat the disease, are effective in only a minority of patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in a very small percentage of patients and have serious side effects.
Patients with FSGS who wish to participate in this study will undergo pre-study evaluation with blood and urine tests. Patients must be on a stable dose of an ACE inhibitor (a drug that lowers blood pressure and reduces proteinuria) for at list 6 months before starting pirfenidone therapy. (Patients who are not already taking an ACE inhibitor will be started on the drug; those who cannot tolerate ACE inhibitors will be given a different drug.) Patients with elevated cholesterol will take a cholesterol-lowering drug. A diet containing approximately 1 gram of protein per kilogram of body weight per day will be recommended.
Patients will take pirfenidone by mouth 3 times a day for 12 months. Blood and urine will be tested once a month, either at NIH or by the patient's local kidney specialist. They will collect two 24-hour urine samples at the beginning of the treatment period, at 2-month intervals throughout the study, and at a 6-month follow-up. Patients will also be asked to give three to five tubes of blood and urine samples for analysis during the study.
In animal studies, pirfenidone improved kidney function and proteinuria and reduced kidney scarring in rats with a disease similar to FSGS. In human studies, pirfenidone improved breathing and survival in patients with lung fibrosis.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Adults greater than or equal to 18 years of age.
- Patients will provide informed consent.
- Biopsy proven FSGS.
- Glomerular filtration rate of at least 25 and no more than 80 ml/minute as assessed by the 4 variable Modification of diet in renal disease GFR equation.
- At least 6 months of renal function data must be available prior to the patient's receiving pirfenidone, and renal function must show a rate of decline of greater than or equal to 0.4 ml/min/month during this baseline period.
- Patients must have received no glucocorticoids, cyclophosphamide, mycophenolate or other immunosuppressive drugs for at least 2 months prior to the study period.
- Patients must have received no cyclosporin for at least 6 months prior to the study period.
- Patients must have been taking an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a stable dose for at least 6 months, unless intolerant of both classes of medication.
- Patients who are HIV seropositive will receive standard care for HIV disease (patients receiving immune-modulating therapy will be excluded).
- Women with child-bearing potential must maintain an effective birth control regimen (oral contraceptive, intrauterine device, barrier plus spermicide).
- Men will be advised that although Ames testing has been negative for any evidence of mutagenicity, they should consider use of contraceptives during the study period as well.
EXCLUSION CRITERIA:
- Inability to give informed consent or cooperate with study.
- Known intolerance to pirfenidone.
- Evidence of FSGS associated with an additional primary or secondary glomerular disease (e.g. diabetes, membranous nephropathy, IgA nephropathy).
- Recent (within 6 months) history of myocardial infarction.
- History of peptic ulcer within 6 months.
- History of cerebrovascular disease manifested by transient ischemic attack or cerebrovascular accident within 6 months.
- Pregnancy, breast feeding or inadequate birth control.
- History of photosensitivity dermatitis.
- Concurrent drug treatment with gemfibrozil, cyclosporin or erythromycin, potassium-sparing diuretics and other drugs which may potentiate hyperkalemia, or concurrent immunosuppresive medications.
- Requirement for NSAID therapy.
- Requirement for interleukin-2 therapy or other immune-modulating medication.
- Existence of any other condition which would complicate the implementation or interpretation of the study.
- Renal transplant.
- Evidence of significant hepatic disease, as indicated by serum transaminases greater than 3 times upper limit of normal, protime greater than 2 seconds prolonged.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in GFR During Treatment Period
Time Frame: 12 months from baseline
|
12 months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proteinuria After Treatment
Time Frame: 12 months from baseline
|
12 months from baseline
|
Proportion of Patients With Positive Change in GFR
Time Frame: 12 months from baseline
|
12 months from baseline
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Abbate M, Zoja C, Rottoli D, Corna D, Perico N, Bertani T, Remuzzi G. Antiproteinuric therapy while preventing the abnormal protein traffic in proximal tubule abrogates protein- and complement-dependent interstitial inflammation in experimental renal disease. J Am Soc Nephrol. 1999 Apr;10(4):804-13. doi: 10.1681/ASN.V104804.
- Bodi I, Kimmel PL, Abraham AA, Svetkey LP, Klotman PE, Kopp JB. Renal TGF-beta in HIV-associated kidney diseases. Kidney Int. 1997 May;51(5):1568-77. doi: 10.1038/ki.1997.215.
- Border WA, Noble NA. Transforming growth factor beta in tissue fibrosis. N Engl J Med. 1994 Nov 10;331(19):1286-92. doi: 10.1056/NEJM199411103311907. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Urological Manifestations
- Urination Disorders
- Nephritis
- Glomerulonephritis
- Fibrosis
- Proteinuria
- Renal Insufficiency
- Glomerulosclerosis, Focal Segmental
- Nephrotic Syndrome
- Nephrosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- 000042
- 00-DK-0042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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