Clinical trial NCT02689778: Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Official title: Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Nephropathy
Albuminuria
Keywords: Pirfenidone
Diabetic nephropathy
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Grupo Medifarma, S. A. de C. V.
First posted: 2016-02-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effect of oral pirfenidone (1800 mg) in albuminuria
timeFrame: 12 months
measure: Effect of oral pirfenidone (1800 mg) in glomerular filtration rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with treatment related adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Study officials:
References: