What is the mechanism of action of this treatment?

Common treatments for kidney failure, particularly those similar to CSL300, often involve anti-inflammatory and cardiovascular agents. These treatments work by reducing systemic inflammation and improving cardiovascular health, which are critical for managing kidney failure. Inflammation and cardiovascular problems exacerbate kidney damage and contribute to the progression of the disease. By mitigating these factors, these treatments can help slow the progression of kidney failure, reduce complications, and improve the quality of life for patients.

What side effects are associated with this type of intervention?

Common treatments for kidney failure, particularly those aimed at reducing systemic inflammation and improving cardiovascular outcomes, include glucocorticoids and PCSK9 inhibitors. Glucocorticoids, while effective in reducing the risk of end-stage kidney disease (ESKD), can cause serious adverse events such as severe infections and hospitalization, especially at higher doses. PCSK9 inhibitors, used to manage cardiovascular risk, are generally well tolerated but can lead to increased exposure in patients with severe renal impairment, potentially causing higher rates of adverse effects. Other side effects of PCSK9 inhibitors include injection site reactions and flu-like symptoms.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of kidney failure have included various immunosuppressive and anti-inflammatory agents. For instance, drugs like cyclosporine, tacrolimus, and sirolimus have been approved to prevent organ rejection post-transplantation by modulating the immune response. Additionally, cardiovascular agents such as diltiazem have been used to improve patient outcomes by managing blood pressure and reducing cardiovascular risks. These treatments aim to enhance graft survival and overall patient health by addressing both immune and cardiovascular factors.

What other types of research exist?

Promising alternatives to CSL300 for kidney failure patients include CEP-33779, eculizumab, and anakinra. CEP-33779 is a JAK2 inhibitor that reduces inflammation, eculizumab is effective in atypical hemolytic uremic syndrome, and anakinra is an IL-1 receptor antagonist that reduces inflammatory cytokines.

← Back to Search

Monoclonal Antibodies

CSL300 for Kidney Failure

Phase 2 & 3

Recruiting

Research Sponsored by CSL Behring

Eligibility Criteria Checklist

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

Must have

A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks

A diagnosis of diabetes mellitus OR ASCVD

Must not have

A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease

Concomitant use of systemic immunosuppressant drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

This trial is testing CSL300, a new treatment, to see if it helps people with heart disease or diabetes who are on dialysis. The study aims to find the right dose and check if it improves heart health by reducing inflammation.

Who is the study for?

Adults with end-stage kidney disease (ESKD) on dialysis for at least 12 weeks can join this trial. They must also have diabetes or atherosclerotic cardiovascular disease (ASCVD), and signs of inflammation shown by high hs-CRP levels. People who were in the earlier part of the study, have certain gastrointestinal conditions, use strong immune system drugs, or have abnormal liver tests cannot participate.

What is being tested?

The study is testing CSL300 against a placebo to find the right dose and see if it helps with heart-related outcomes in patients with ESKD undergoing dialysis. It's organized into two parts: first finding the correct dosage and then checking its effectiveness and safety.

What are the potential side effects?

Possible side effects may include reactions related to immune system suppression since CSL300 is likely an immunomodulatory drug. Specific side effects are not listed but could be similar to those seen with other drugs that affect the immune system.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been on dialysis for my kidney failure for at least 12 weeks.

Select...

I have been diagnosed with diabetes or heart and blood vessel disease.

Exclusion Criteria

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

Select...

I have had GI perforation, inflammatory bowel disease, or peptic ulcer disease.

Select...

I am currently taking drugs that suppress my immune system.

Select...

I do not have a condition expected to cause death within a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Mean change from Baseline in lipid panel (Phase 2b)

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: CSL300 (medium dose)(Phase 2b)Experimental Treatment1 Intervention

IV administration

Group II: CSL300 (low dose)(Phase 2b)Experimental Treatment1 Intervention

Intravenous (IV) administration

Group III: CSL300 (high dose)(Phase 2b)Experimental Treatment1 Intervention

IV administration

Group IV: CSL300 (Phase 3)Experimental Treatment1 Intervention

IV administration

Group V: Placebo (Phase 2b)Placebo Group1 Intervention

IV administration

Group VI: Placebo (Phase 3)Placebo Group1 Intervention

IV administration

0 / 5Eligibility 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 kidney failure, particularly those similar to CSL300, often involve anti-inflammatory and cardiovascular agents. These treatments work by reducing systemic inflammation and improving cardiovascular health, which are critical for managing kidney failure. Inflammation and cardiovascular problems exacerbate kidney damage and contribute to the progression of the disease. By mitigating these factors, these treatments can help slow the progression of kidney failure, reduce complications, and improve the quality of life for patients.

Molecular targeting of renal inflammation using drug delivery technology to inhibit NF-κB improves renal recovery in chronic kidney disease.Alkali supplementation as a therapeutic in chronic kidney disease: what mediates protection?The inflammatory cascade in acute ischemic renal failure.