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

NCT ID: NCT02689778

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-12-31

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.

Conditions

Diabetic Nephropathy; Albuminuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pirfenidone

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

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: DRUG

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

Placebo

Oral placebo with breakfast and with dinner for 12 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical tablets without active substance

Interventions

Pirfenidone

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

Intervention Type: DRUG

Placebo

Identical tablets without active substance

Intervention Type: DRUG

Other Intervention Names

Kitoscell LP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Medifarma, S. A. de C. V.

INDUSTRY

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

1497

Identifier Type: -

Identifier Source: org_study_id