Clofutriben for Chronic Kidney Disease

(RENAL Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sparrow Pharmaceuticals

Disqualifiers: Abnormal ECG, Safety risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 days

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called clofutriben for people with chronic kidney disease. Researchers aim to determine the safety and tolerability of this treatment for those with moderate kidney issues. The trial includes two groups: one with kidney problems and another with normal kidney function. It suits individuals with stable moderate kidney disease who wish to help test new treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if your medications could increase safety risks, you might not be eligible to participate.

Is there any evidence suggesting that Clofutriben is likely to be safe for humans?

Research has shown that clofutriben has undergone safety testing in several studies. In one study on endogenous Cushing's syndrome, all patients who completed the study chose to continue using the treatment, suggesting they found it manageable. Additionally, the FDA has given clofutriben special recognition for another condition, indicating its potential benefits and safety in certain cases.

While these studies do not provide clear information about side effects, this is a Phase 1 trial. Phase 1 trials primarily test the treatment's safety for people. Although some safety information might be available, the research is still in its early stages. Participants in these trials receive close monitoring for any negative effects.

Overall, while clofutriben appears promising and has been well-tolerated in some studies, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for chronic kidney disease (CKD) focus on managing symptoms or slowing disease progression through medications like ACE inhibitors or angiotensin II receptor blockers. But Clofutriben works differently, as it targets a novel pathway believed to play a role in kidney function, which could offer a more direct approach to addressing the underlying disease. Researchers are excited about Clofutriben because it represents a potential breakthrough in how CKD is treated, with the promise of improving kidney health beyond what current options offer. Additionally, this treatment's unique mechanism may lead to fewer side effects, which is a significant advantage over existing therapies.

What evidence suggests that Clofutriben might be an effective treatment for chronic kidney disease?

Research has shown that clofutriben, a powerful and targeted drug, might help improve chronic kidney disease by targeting a specific enzyme involved in hormone production. Early results suggest it can manage the disease with fewer side effects than other treatments. Limited data from past studies indicate it may improve health without causing adrenal insufficiency, a condition where the adrenal glands don't produce enough hormones. Although primarily studied for other conditions, clofutriben has been noted for its potential benefits and has received special recognition for treating certain rare disorders. These early signs suggest that clofutriben could be a promising treatment option for chronic kidney disease. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic kidney disease, specifically those with moderate renal impairment. It will also include matched control participants who have normal renal function.

Inclusion Criteria

I have moderate kidney problems or my kidneys are healthy and I match another participant.

Exclusion Criteria

Participant whose current or recent medical conditions, medications, or procedures could increase participant's safety risk, or whom the Investigator considers not suitable for entry into the trial or the participant, or who has clinically significant abnormal 12-lead electrocardiogram (ECG)/ vital sign measurements/ laboratory test results at Screening and Check-in, will not be enrolled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are confined to a clinical research unit for 6 days and receive a single oral dose of clofutriben. Clofutriben PK, safety, and tolerability are assessed.

6 days

Follow-up

Participants are contacted by telephone 4 weeks after clofutriben administration for safety follow-up.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clofutriben

Trial Overview The study is testing a single dose of a drug called clofutriben (12mg) to understand how it's processed in the body when kidney function is impaired compared to normal.

How Is the Trial Designed?

Group I: clofutriben Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sparrow Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

160+

Citations

1. ard.eular.org ard.eular.org/article/S0003-4967(25)04454-1/fulltext

Effects of clofutriben, a selective 11β-hydroxysteroid ... Objectives of the trial were to learn whether prednisolone with clofutriben shows similar disease control, and less toxicity, compared to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07227922

Clofutriben Pharmacokinetics in Patients With Impaired ... Inclusion Criteria: Male and female participants with stable moderate renal impairment (estimated glomerular filtration rate [eGFR]: 30 to <60 ...

3. pharmacytimes.com pharmacytimes.com/view/clofutriben-receives-fda-orphan-drug-designation-to-treat-endogenous-cushing-syndrome

Clofutriben Receives FDA Orphan Drug Designation to ... The FDA granted orphan drug designation for clofutriben (Sparrow Pharmaceuticals), a potent and selective HSD-1 inhibitor, for the treatment of endogenous ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12544585/

OR12-04 Clofutriben, an 11beta-Hydroxysteroid ... Results: Mean baseline HSD-1 ratio was 1.95 ... These limited data support clofutriben's potential for clinical improvement without adrenal insufficiency.

5. sparrowpharma.com sparrowpharma.com/news/sparrowendo2-r5283-p222h

Sparrow Pharmaceuticals The new data suggest that clofutriben might step off that spectrum, achieving efficacy without dose titration and with a low risk of AI.

6. cushingsdiseasenews.com cushingsdiseasenews.com/news/clofutriben-shows-promise-endogenous-cushings-syndrome-trial/

Clofutriben shows promise in trial for endogenous ... Clofutriben shows promise in trial for endogenous Cushing's syndrome. All patients completing RESCUE trial chose to continue on treatment.