Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001959
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2000-01-18
Brief Title:
Pirfenidone to Treat Kidney Disease Focal Segmental Glomerulosclerosis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pirfenidone in Focal Segmental GlomerulosclerosisPhase II Study
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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
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 patients 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
Detailed Description:
The objective of this pilot phase II trial is to evaluate the ability of pirfenidone a novel anti-fibrotic agent to reduce the proteinuria and slow the rate of progression of renal insufficiency in patients with focal segmental glomerulosclerosis FSGS We will enroll 25 patients with renal biopsy proven FSGS and evidence of impaired renal function glomerular filtration rate GFR of 10-80 mlmin after 102 must have GFR greater than 25 mlmin as assessed by the 4 variable Modification of Diet in Renal Disease equation As standard of care therapy all patients will also receive angiotensin converting enzyme inhibitor ACEI therapy and will receive an HMG Co-A reductase inhibitor drug if hypercholesterolemic Preliminary evaluation will assure that the patients meet the study requirements and an evaluation period will be used to ensure that patients are on maximal conservative therapy prior to the baseline period Patients will receive treatment with pirfenidone daily with dose adjusted for body weight and level of kidney function The primary end point will be the decrease glomerular filtration as a marker of glomerular injury reduction in proteinuria will be a secondary end-point If the pilot study suggests this drug delays progression of renal insufficiency or reduces proteinuria in patients with FSGS we will proceed with a large scale randomized placebo-controlled study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-DK-0042 | None | None | None |