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

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Unknown status

CT.gov ID

NCT02689778

Collaborator

Grupo Medifarma, S. A. de C. V. (Industry)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy Albuminuria	Drug: Pirfenidone Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pirfenidone Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months.	Drug: Pirfenidone Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months. Other Names: Kitoscell LP
Placebo Comparator: Placebo Oral placebo with breakfast and with dinner for 12 months.	Drug: Placebo Identical tablets without active substance

Arm

Intervention/Treatment

Experimental: Pirfenidone

Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months.

Drug: Pirfenidone

Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.

Other Names:

Kitoscell LP

Placebo Comparator: Placebo

Oral placebo with breakfast and with dinner for 12 months.

Drug: Placebo

Identical tablets without active substance

Outcome Measures

Primary Outcome Measures

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

Number of patients with treatment related adverse events [12 months]
hypersensitivity, photosensitivity, liver function test alteration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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