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Anti-fibrotic agent

Pirfenidone for Chronic Kidney Disease (TOP-CKD Trial)

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

Must not have

Anticipated need for dialysis or kidney transplantation within 12 months

Inability or unwillingness to travel to study visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 18

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might need dialysis or a kidney transplant within a year.

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I cannot or do not want to travel for study visits.

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My heart's electrical activity test shows a QTc interval over 500 msec.

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I have liver disease, drink more than 14 alcoholic drinks a week, or have high liver enzyme levels.

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I have been diagnosed with idiopathic pulmonary fibrosis.

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I or someone in my family has long QT Syndrome.

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I have been diagnosed with a genetic kidney disease.

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I am taking or plan to take drugs that may interact with pirfenidone.

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I have not been hospitalized in the last 30 days, except for short observations.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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).

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 / 11Eligibility criteria met