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Anti-fibrotic agent

Pirfenidone for Chronic Kidney Disease (TOP-CKD Trial)

Q: Is there any precedent for this groundbreaking research?

<p>The original research study of <a href="https://www.withpower.com/clinical-trials/experimental">Experimental</a>, pirfenidone was commissioned by Shanghai Genomics, Inc. and first conducted in 2015 with a sample size of 48 participants. Following the Phase 2 drug approval achieved from this initial trial, 12 additional tests are currently taking place across 11 cities located in 5 countries.</p>

Phase 2

Recruiting

Led By Joachim H Ix, MD,MAS

Research Sponsored by Veterans Medical Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with eGFR ≥20 ml/min/1.73m2 using the CKD-EPI Creatinine equation

Age 21 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 18

Awards & highlights

TOP-CKD Trial Summary

This trial will use MRI imaging scans and urinary markers to test the efficacy of pirfenidone as a treatment for kidney disease.

Who is the study for?

Adults over 21 with chronic kidney disease and a certain risk of kidney failure can join this trial. They must have a specific level of kidney function, not be using tobacco, and cannot have had cancer (with some exceptions), liver disease, uncontrolled psychiatric illness, or substance abuse recently. Pregnant women and those planning to become pregnant are excluded.Check my eligibility

What is being tested?

The study is testing Pirfenidone against a placebo to see if it can prevent worsening of chronic kidney disease by reducing scarring in the kidneys. Participants will also undergo MRI scans and urine tests to measure the severity of their kidney scarring.See study design

What are the potential side effects?

Pirfenidone may cause side effects like stomach discomfort, skin reactions due to light sensitivity, fatigue, headache, dizziness, loss of appetite or weight loss. It might also affect liver function tests.

TOP-CKD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is adequate, with an eGFR of 20 or higher.

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I am 21 years old or older.

TOP-CKD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in kidney fibrosis, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI).

Change from baseline in kidney fibrosis, as assessed by urinary markers of tubulo-interstitial fibrosis.

Secondary outcome measures

Change from baseline in kidney function, as assessed by eGFR.

Change from baseline in kidney function, as assessed by urine albumin to creatinine ratio (ACR).

TOP-CKD Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Experimental, pirfenidoneActive Control1 Intervention

Pirfenidone 267 mg capsules Randomized participants will take 5 capsules (1335 mg pirfenidone): 2 pills in the morning, 1 mid-day, and 2 in the evening, with meals.

Group II: Placebo, pirfenidonePlacebo Group1 Intervention

Pirfenidone placebo capsules Randomized participants will take 5 capsules (1335 mg pirfenidone): 2 pills in the morning, 1 mid-day, and 2 in the evening, with meals.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Veterans Medical Research FoundationLead Sponsor

43 Previous Clinical Trials

4,734 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,391 Total Patients Enrolled

San Diego Veterans Healthcare SystemFED

34 Previous Clinical Trials

3,706 Total Patients Enrolled

Media Library

Pirfenidone (Anti-fibrotic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258397 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate quantity of participants registered for this research?

"Affirmative. Per the information on clinicaltrials.gov, this research study is recruiting patients currently. It was first listed in October 26th 2020 and revised most recently on April 25th 2022; 200 participants are needed from 2 sites for its completion."

Answered by AI

Are any new participants being accepted for this clinical trial?

"Indeed, according to the clinicaltrials.gov webpage this experiment is currently attempting to enroll subjects. It was unveiled on October 26th 2020 and last revised April 25th 2022. The research necessitates 200 volunteers from two medical facilities."

Answered by AI

What other research initiatives have included the use of pirfenidone?

"Currently, 12 clinical trials are assessing the efficacy of experimental pirfenidone with 1 study being in its last phase. These studies have been distributed across 14 locations - chiefly Mayaguez, Pennsylvania."

Answered by AI

Is there any precedent for this groundbreaking research?

"The original research study of Experimental, pirfenidone was commissioned by Shanghai Genomics, Inc. and first conducted in 2015 with a sample size of 48 participants. Following the Phase 2 drug approval achieved from this initial trial, 12 additional tests are currently taking place across 11 cities located in 5 countries."

Answered by AI

What are the security implications of utilizing pirfenidone for medical purposes?

"According to our team at Power, the safety rating for experimental pirfenidone is 2. This score was determined since this Phase 2 trial has some evidence of efficacy but lacks supporting data regarding its effectiveness."

Answered by AI

Recent research and studies

Nephron Clinical PracticeJournal

Assessment and Clinical Aspects of Health-related Quality of Life in Dialysis Patients and Patients with Chronic Kidney Disease

Molsted, Stig, Lotte Prescott, James Heaf, and Inge Eidemak. 2007. “Assessment and Clinical Aspects of Health-related Quality of Life in Dialysis Patients and Patients with Chronic Kidney Disease”. Nephron Clinical Practice. S. Karger AG. doi:10.1159/000101481.

Journal of the American Society of NephrologyJournal

Pirfenidone for Diabetic Nephropathy

Sharma, Kumar, Joachim H. Ix, Anna V. Mathew, Monique Cho, Axel Pflueger, Stephen R. Dunn, Barbara Francos, et al.. 2011. “Pirfenidone for Diabetic Nephropathy”. Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.1681/asn.2010101049.

Clinical Journal of the American Society of NephrologyJournal

Pirfenidone Slows Renal Function Decline in Patients with Focal Segmental Glomerulosclerosis

Cho, Monique E., David C. Smith, Mary H. Branton, Scott R. Penzak, and Jeffrey B. Kopp. 2007. “Pirfenidone Slows Renal Function Decline in Patients with Focal Segmental Glomerulosclerosis”. Clinical Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.2215/cjn.01050207.

The LancetJournal