Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy (PenDaNt)

March 7, 2025 updated by: Sidrah Lodhi

Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • King Edward Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Pirfenidone)
Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months
Drug: Pirfenidone
Capsule Pirfenidone 1200mg/ day in divided doses for 3 months
Placebo Comparator: Group B
Placebo capsules - 2 X 8hrly for 3 months
Other: Placebo
2 Capsules 3 times a day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
15% improvement in eGFR
Time Frame: 6 months
eGFR of the patients shall be evaluated for at least 15% improvement
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Adverse Effects of Drugs
Time Frame: 6 months
Adverse Effects of the drugs
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidrah Lodhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2024

Primary Completion (Actual)

March 7, 2025

Study Completion (Actual)

March 7, 2025

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 483/RC/KEMU/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Nephropathies

Clinical Trials on Pirfenidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe