Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00001959
• Date of registration: 18/01/2000
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
• Scientific title: Pirfenidone in Focal Segmental Glomerulosclerosis:Phase II Study
• Date of first enrolment: December 1999
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00001959
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. Adults greater than or equal to 18 years of age.

2. Patients will provide informed consent.

3. Biopsy proven FSGS.

4. 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.

5. 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.

6. Patients must have received no glucocorticoids, cyclophosphamide, mycophenolate
or other immunosuppressive drugs for at least 2 months prior to the study period.

7. Patients must have received no cyclosporin for at least 6 months prior to the
study period.

8. 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.

9. Patients who are HIV seropositive will receive standard care for HIV disease
(patients receiving immune-modulating therapy will be excluded).

10. Women with child-bearing potential must maintain an effective birth control
regimen (oral contraceptive, intrauterine device, barrier plus spermicide).

11. 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:

1. Inability to give informed consent or cooperate with study.

2. Known intolerance to pirfenidone.

3. Evidence of FSGS associated with an additional primary or secondary glomerular disease
(e.g. diabetes, membranous nephropathy, IgA nephropathy).

4. Recent (within 6 months) history of myocardial infarction.

5. History of peptic ulcer within 6 months.

6. History of cerebrovascular disease manifested by transient ischemic attack or
cerebrovascular accident within 6 months.

7. Pregnancy, breast feeding or inadequate birth control.

8. History of photosensitivity dermatitis.

9. Concurrent drug treatment with gemfibrozil, cyclosporin or erythromycin,
potassium-sparing diuretics and other drugs which may potentiate hyperkalemia, or
concurrent immunosuppresive medications.

10. Requirement for NSAID therapy.

11. Requirement for interleukin-2 therapy or other immune-modulating medication.

12. Existence of any other condition which would complicate the implementation or
interpretation of the study.

13. Renal transplant.

14. Evidence of significant hepatic disease, as indicated by serum transaminases greater
than 3 times upper limit of normal, protime greater than 2 seconds prolonged.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fibrosis

Kidney Failure

Nephrotic Syndrome

Proteinuria

Focal Glomerulosclerosis

Intervention(s)

Drug: Pirfenidone

Primary Outcome(s)

Decrease in GFR During Treatment Period [Time Frame: 12 months from baseline]

Secondary Outcome(s)

Proteinuria After Treatment [Time Frame: 12 months from baseline]

Proportion of Patients With Positive Change in GFR [Time Frame: 12 months from baseline]

Secondary ID(s)

00-DK-0042

000042

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00001959