NCT02689778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 14, 2023

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

February 12, 2016

Last Update Submit

March 13, 2023

Conditions

Diabetic NephropathyAlbuminuria

Keywords

PirfenidoneDiabetic nephropathy

Outcome Measures

Primary Outcomes (2)

  • Effect of oral pirfenidone (1800 mg) in albuminuria

    12 months

  • Effect of oral pirfenidone (1800 mg) in glomerular filtration rate

    12 months

Secondary Outcomes (1)

  • Number of patients with treatment related adverse events

    12 months

Study Arms (2)

Pirfenidone

EXPERIMENTAL

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

Drug: Pirfenidone

Placebo

PLACEBO COMPARATOR

Oral placebo with breakfast and with dinner for 12 months.

Drug: Placebo

Interventions

PirfenidoneDRUG

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

Also known as: Kitoscell LP
Pirfenidone
PlaceboDRUG

Identical tablets without active substance

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Diabetic NephropathiesAlbuminuria

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 24, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 14, 2023

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)