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

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ClinicalTrials.gov Identifier: NCT02689778
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Grupo Medifarma, S. A. de C. V.
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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 Type : Interventional  (Clinical Trial)
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 : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

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 Name: Kitoscell LP

Placebo Comparator: Placebo
Oral placebo with breakfast and with dinner for 12 months.
Drug: Placebo
Identical tablets without active substance




Primary Outcome Measures :
  1. Effect of oral pirfenidone (1800 mg) in albuminuria [ Time Frame: 12 months ]
  2. Effect of oral pirfenidone (1800 mg) in glomerular filtration rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of patients with treatment related adverse events [ Time Frame: 12 months ]
    hypersensitivity, photosensitivity, liver function test alteration



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689778


Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Mexico City, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Grupo Medifarma, S. A. de C. V.

Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02689778     History of Changes
Other Study ID Numbers: 1497
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Pirfenidone
Diabetic nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Albuminuria
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents