Albuminuria, Diabetic Nephropathy
Conditions
Keywords
Pirfenidone, Diabetic nephropathy
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.
Interventions
DRUGPirfenidone
Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.
DRUGPlacebo
Identical tablets without active substance
Sponsors
Grupo Medifarma, S. A. de C. V.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment related adverse events | 12 months | hypersensitivity, photosensitivity, liver function test alteration |
Countries
Mexico
Outcome results
None listed