Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy (PenDaNt)

S

Sidrah Lodhi

Status and phase

Enrolling
Phase 4

Conditions

Diabetic Nephropathies
Type 2 Diabetes

Treatments

Other: Placebo
Drug: Pirfenidone

Study type

Interventional

Funder types

Other

Identifiers

NCT06224790
483/RC/KEMU/2022

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

Group A (Pirfenidone)
Experimental group
Description:
Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months
Treatment:
Drug: Pirfenidone
Group B
Placebo Comparator group
Description:
Placebo capsules - 2 X 8hrly for 3 months
Treatment:
Other: Placebo

Trial contacts and locations

1

Loading...

Central trial contact

AP Endocrinology

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems