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

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

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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