Perfenidone in Type 2 Diabetic Patients With Diabetic Neu... | NCT06224790

Studies
Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy

NCT06224790

Sponsor

Sidrah Lodhi

Status

Completed

Last Update Posted

Mar 11, 2025Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Diabetic Nephropathies
Type 2 Diabetes

Interventions

Pirfenidone
Placebo

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2024Actual

Primary Completion Date

Mar 7, 2025Actual

Completion Date

Mar 7, 2025Actual

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2025

Last Update Posted Date

Mar 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pirfenidone	Drug	Capsule Pirfenidone 1200mg/ day in divided doses for 3 months	Group A (Pirfenidone)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
15% improvement in eGFR	eGFR of the patients shall be evaluated for at least 15% improvement	6 months

Secondary Outcomes

Measure	Description	Time Frame
Safety - Adverse Effects of Drugs	Adverse Effects of the drugs	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Edward Medical University		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093844	pirfenidone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided