NCT06224790

Brief Summary

The purpose of this study is to determine the effectiveness \& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_4

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

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

January 16, 2024

Last Update Submit

March 7, 2025

Conditions

Diabetic NephropathiesType 2 Diabetes

Keywords

Type 2 Diabetes MellitusDiabetic NephropathyPerfenidone

Outcome Measures

Primary Outcomes (1)

  • 15% improvement in eGFR

    eGFR of the patients shall be evaluated for at least 15% improvement

    6 months

Secondary Outcomes (1)

  • Safety - Adverse Effects of Drugs

    6 months

Study Arms (2)

Group A (Pirfenidone)

EXPERIMENTAL

Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months

Drug: Pirfenidone

Group B

PLACEBO COMPARATOR

Placebo capsules - 2 X 8hrly for 3 months

Other: Placebo

Interventions

PirfenidoneDRUG

Capsule Pirfenidone 1200mg/ day in divided doses for 3 months

Group A (Pirfenidone)
PlaceboOTHER

2 Capsules 3 times a day for 3 months

Group B

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c \<7.5% Patient taking ACEi/ARB for at least 3 months BP \<140/90

You may not qualify if:

  • History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 2

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

March 10, 2024

Primary Completion

March 7, 2025

Study Completion

March 7, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)