Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy

Phase 4

Completed

• Conditions: Diabetic Nephropathies; Type 2 Diabetes
• Interventions: Other: Placebo; Drug: Pirfenidone

• Registration Number: NCT06224790
• Lead Sponsor: Sidrah Lodhi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Study Start: 2024-03-10
• Status Verified: 2025-03
• Primary Completion: 2025-03-07
• Study Completion: 2025-03-07
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Placebo	Placebo capsules - 2 X 8hrly for 3 months
Group A (Pirfenidone)	Pirfenidone	Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months

Primary Outcome Measures

Name	Time	Method
15% improvement in eGFR	6 months	eGFR of the patients shall be evaluated for at least 15% improvement

Secondary Outcome Measures

Name	Time	Method
Safety - Adverse Effects of Drugs	6 months	Adverse Effects of the drugs

Trial Locations

Locations (1)

King Edward Medical University; 🇵🇰 Lahore, Punjab, Pakistan