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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Nephropathy, Albuminuria

Intervention / Treatment
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* Drug: Pirfenidone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirfenidone<br>Oral pirfenidone 600 mg with breakfast and 1200 mg with dinner for 12 months. | Drug: Pirfenidone<br>* Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.<br>* Other names: Kitoscell LP;|
| Placebo Comparator: Placebo<br>Oral placebo with breakfast and with dinner for 12 months. | Drug: Placebo<br>* Identical tablets without active substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment related adverse events | hypersensitivity, photosensitivity, liver function test alteration | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pirfenidone, Diabetic nephropathy