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

Phase 3

Completed

• Conditions: Diabetic Nephropathy; Albuminuria
• Interventions: Drug: Placebo; Drug: Pirfenidone

• Registration Number: NCT02689778
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Study Start: 2016-03
• Status Verified: 2019-08
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral placebo with breakfast and with dinner for 12 months.
Pirfenidone	Pirfenidone	Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months.

Primary Outcome Measures

Name	Time	Method
Effect of oral pirfenidone (1800 mg) in albuminuria	12 months
Effect of oral pirfenidone (1800 mg) in glomerular filtration rate	12 months

Secondary Outcome Measures

Name	Time	Method
Number of patients with treatment related adverse events	12 months	hypersensitivity, photosensitivity, liver function test alteration

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ); 🇲🇽 Mexico City, Mexico