Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathy, Albuminuria
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Pirfenidone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Pirfenidone, Diabetic nephropathy
Eligibility Criteria
Inclusion criteria
- Body mass index (BMI) less than 35 kg/m2
- Diagnosis of diabetes mellitus type 2
- Glomerular filtration rate of 15-89 ml/min
- Albuminuria ≥30 mg/24 h and < 3.5 g/24 h
- Individuals with blood pressure less than 140/90 mmHg or treated with stable doses of anti-hypertensive drugs.
- Glycated hemoglobin <10%
Exclusion criteria
- Another etiology of renal disease (autoimmune diseases, polycystic kidney disease)
- Repeated urinary tract infections (more than three episodes in the past year)
- Photosensitivity to any drug
- Liver disease
- Pregnancy
- Breastfeeding
Sites / Locations
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pirfenidone
Placebo
Arm Description
Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months.
Oral placebo with breakfast and with dinner for 12 months.
Outcomes
Primary Outcome Measures
Effect of oral pirfenidone (1800 mg) in albuminuria
Effect of oral pirfenidone (1800 mg) in glomerular filtration rate
Secondary Outcome Measures
Number of patients with treatment related adverse events
hypersensitivity, photosensitivity, liver function test alteration
Full Information
NCT ID
NCT02689778
First Posted
February 12, 2016
Last Updated
March 13, 2023
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Grupo Medifarma, S. A. de C. V.
1. Study Identification
Unique Protocol Identification Number
NCT02689778
Brief Title
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Official Title
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Grupo Medifarma, S. A. de C. V.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is estimated that approximately 30% of patients with diabetes develop diabetic nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis, control or blocking these mechanisms are therefore potential therapeutical targets for this entity. Current treatment options are based on the glycemic control, blood pressure control, as well as the use of medications such as angiotensin-converting enzyme inhibitors and Angiotensin II receptor antagonists, these actions are not enough to stop progression. Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties. Although the specific mechanism is unknown, pirfenidone interferes with the expression, secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients with type 2 diabetes and nephropathy. The period of time the treatment will be administered will be of 12 months, 62 patients will be included. The primary outcome will be improvement in glomerular filtration rate. The secondary outcomes will be number of patients requiring replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF - β. Change in these parameters will be evaluated at the end of the treatment period (12 months). Throughout the study the incidence of adverse events will be recorded, wich will allow us to learn about the safety and security of the drug in this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Albuminuria
Keywords
Pirfenidone, Diabetic nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pirfenidone
Arm Type
Experimental
Arm Description
Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo with breakfast and with dinner for 12 months.
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Other Intervention Name(s)
Kitoscell LP
Intervention Description
Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical tablets without active substance
Primary Outcome Measure Information:
Title
Effect of oral pirfenidone (1800 mg) in albuminuria
Time Frame
12 months
Title
Effect of oral pirfenidone (1800 mg) in glomerular filtration rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of patients with treatment related adverse events
Description
hypersensitivity, photosensitivity, liver function test alteration
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Body mass index (BMI) less than 35 kg/m2
Diagnosis of diabetes mellitus type 2
Glomerular filtration rate of 15-89 ml/min
Albuminuria ≥30 mg/24 h and < 3.5 g/24 h
Individuals with blood pressure less than 140/90 mmHg or treated with stable doses of anti-hypertensive drugs.
Glycated hemoglobin <10%
Exclusion criteria
Another etiology of renal disease (autoimmune diseases, polycystic kidney disease)
Repeated urinary tract infections (more than three episodes in the past year)
Photosensitivity to any drug
Liver disease
Pregnancy
Breastfeeding
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
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