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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06224790
Other study ID # 483/RC/KEMU/2022
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 10, 2024
Est. completion date March 9, 2025

Study information

Verified date January 2024
Source King Edward Medical University
Contact AP Endocrinology
Phone 03004683473
Email sidrah.lodhi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 9, 2025
Est. primary completion date March 9, 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility 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


Intervention

Drug:
Pirfenidone
Capsule Pirfenidone 1200mg/ day in divided doses for 3 months
Other:
Placebo
2 Capsules 3 times a day for 3 months

Locations

Country Name City State
Pakistan King Edward Medical University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Sidrah Lodhi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 15% improvement in eGFR 15% improvement in eGFR 6 months
Secondary Safety - Adverse Effects of Drugs Adverse Effects of the drugs 6 months
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