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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 belowSelect...
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
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
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.
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.
Find a Location
Who is running the clinical trial?
CSL BehringLead Sponsor
198 Previous Clinical Trials
1,209,141 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring LLC
1,270 Previous Clinical Trials
501,741 Total Patients Enrolled
2 Trials studying Kidney Failure
417 Patients Enrolled for Kidney Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on dialysis for my kidney failure for at least 12 weeks.I am 18 years old or older.I have had GI perforation, inflammatory bowel disease, or peptic ulcer disease.I am currently taking drugs that suppress my immune system.Your liver function tests are not normal.I have been diagnosed with diabetes or heart and blood vessel disease.I do not have a condition expected to cause death within a year.Your blood test shows high levels of hs-CRP (a marker of inflammation).
Research Study Groups:
This trial has the following groups:- Group 1: CSL300 (high dose)(Phase 2b)
- Group 2: CSL300 (low dose)(Phase 2b)
- Group 3: CSL300 (medium dose)(Phase 2b)
- Group 4: Placebo (Phase 2b)
- Group 5: CSL300 (Phase 3)
- Group 6: Placebo (Phase 3)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 0 awards, including:Share this study with friends
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