What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include finerenone, glucocorticoids, and calcineurin inhibitors. Finerenone can cause hyperkalemia, leading to discontinuation in some patients. Glucocorticoids, such as methylprednisolone, are associated with serious adverse events like severe infections and Cushingoid features, especially at higher doses. Calcineurin inhibitors, including cyclosporine and tacrolimus, may lead to infections, impaired glucose tolerance, and weight gain. These treatments aim to manage CKD but come with significant side effects that require careful monitoring.

What prior FDA approvals exist?

Several FDA-approved drugs have been used in the treatment of Chronic Kidney Disease (CKD). These include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which are commonly prescribed to manage hypertension and slow CKD progression. Additionally, tolvaptan has been approved for treating autosomal dominant polycystic kidney disease (ADPKD) to slow kidney function decline. Immunosuppressive agents like cyclophosphamide and glucocorticoids are used in specific cases of CKD with underlying autoimmune conditions, such as IgA nephropathy and anti-GBM disease. These treatments aim to manage symptoms, slow disease progression, and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to KT-301 for managing or treating CKD include AST-120, which has shown potential in delaying dialysis initiation and improving prognosis in pre-dialysis CKD patients, and TRF-budesonide, which has demonstrated efficacy in reducing proteinuria and stabilizing eGFR in patients with IgA nephropathy. Additionally, mineralocorticoid receptor antagonists like KBP-5074 are being evaluated for their efficacy and safety in patients with advanced CKD and resistant hypertension.

← Back to Search

Unknown

Long-Term Safety of KT-301 for Chronic Kidney Disease

Phase 2 & 3

Waitlist Available

Research Sponsored by Kibow Pharma

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Unwilling or unable to visit the site for the follow-up visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests KT-301, a probiotic, in CKD Stage IV patients. KT-301 aims to improve gut health by balancing good bacteria, which helps reduce harmful substances and inflammation. Probiotics have shown promise in improving symptoms and quality of life, reducing inflammation, and delaying the progression of kidney failure in CKD patients.

Who is the study for?

This trial is for adults aged 18-80 with Chronic Kidney Disease (CKD) stage IV who finished the US-APR2020-01 study. It's not open to those who didn't participate or withdrew from that initial study, or can't commit to follow-up visits.

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called KT-301 in patients with CKD IV. This extension follows an earlier phase where participants already received this treatment.

What are the potential side effects?

Since this is an extension of a previous trial, side effects are likely similar to those observed before which may include issues related to kidney function, blood pressure changes, and potential impacts on other organ systems.

Eligibility Criteria

Exclusion Criteria

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

Select...

I cannot or do not want to go to the site for follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV

Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: KT-301 (formerly US-APR2020)Experimental Treatment1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for renal disease, particularly chronic kidney disease (CKD), include medications like SGLT2 inhibitors and GLP-1 receptor agonists, which help reduce kidney disease progression and improve glycemic control. Immunosuppressive therapies such as cyclophosphamide and corticosteroids are used to manage autoimmune conditions like anti-GBM disease by reducing inflammation and autoantibody production. These treatments are vital for slowing kidney damage, reducing cardiovascular risks, and improving patient outcomes, thereby preventing the progression to end-stage renal disease.

Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial.Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.