Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689778
• Other study ID #: 1497
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Albuminuria
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Pirfenidone
Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.
• Placebo
Identical tablets without active substance

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Grupo Medifarma, S. A. de C. V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of oral pirfenidone (1800 mg) in albuminuria		12 months
Primary	Effect of oral pirfenidone (1800 mg) in glomerular filtration rate		12 months
Secondary	Number of patients with treatment related adverse events	hypersensitivity, photosensitivity, liver function test alteration	12 months