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Completed

NCT Number: NCT06224790

Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy

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

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Key information

Conditions

Diabetic Nephropathies Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

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

Placebo

Other

2 Capsules 3 times a day for 3 months

Primary outcomes

  1. 15% improvement in eGFR

    Time frame: 6 months

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

Secondary outcomes

  1. Safety - Adverse Effects of Drugs

    Time frame: 6 months

    Adverse Effects of the drugs

Sponsors and collaborators

Lead sponsor

Sidrah Lodhi

Other

Registry information

Official study title

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

Acronym: PenDaNt

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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