Diabetic Nephropathies, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Perfenidone
Brief summary
The purpose of this study is to determine the effectiveness & safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy
Interventions
DRUGPirfenidone
Capsule Pirfenidone 1200mg/ day in divided doses for 3 months
OTHERPlacebo
2 Capsules 3 times a day for 3 months
Sponsors
Sidrah Lodhi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 15% improvement in eGFR | 6 months | eGFR of the patients shall be evaluated for at least 15% improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Adverse Effects of Drugs | 6 months | Adverse Effects of the drugs |
Countries
Pakistan
Outcome results
None listed