Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02689778|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy Albuminuria||Drug: Pirfenidone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||December 2019|
Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months.
Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.
Other Name: Kitoscell LP
Placebo Comparator: Placebo
Oral placebo with breakfast and with dinner for 12 months.
Identical tablets without active substance
- Effect of oral pirfenidone (1800 mg) in albuminuria [ Time Frame: 12 months ]
- Effect of oral pirfenidone (1800 mg) in glomerular filtration rate [ Time Frame: 12 months ]
- Number of patients with treatment related adverse events [ Time Frame: 12 months ]hypersensitivity, photosensitivity, liver function test alteration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689778
|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)|
|Mexico City, Mexico, 14080|