Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy

NCT ID: NCT06224790

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-10

Study Completion Date

2025-03-07

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Nephropathies Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A (Pirfenidone)

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

Group Type EXPERIMENTAL

Pirfenidone

Intervention Type DRUG

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

Group B

Placebo capsules - 2 X 8hrly for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 Capsules 3 times a day for 3 months

Interventions

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Pirfenidone

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

Intervention Type DRUG

Placebo

2 Capsules 3 times a day for 3 months

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sidrah Lodhi

OTHER

Sponsor Role lead

Responsible Party

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Sidrah Lodhi

Assistant Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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King Edward Medical University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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483/RC/KEMU/2022

Identifier Type: -

Identifier Source: org_study_id

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