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This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in Chinese participants with end stage kidney disease (ESKD) undergoing dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL300 (Clazakizumab) | Experimental | Participants will receive CSL300 once every 4 weeks (Q4W) as a slow intravenous (IV) bolus, for a total of 20 weeks during the Treatment Period. |
|
| Placebo | Placebo Comparator | Participants will receive a placebo matching to CSL300 Q4W as a slow IV bolus, for a total of 20 weeks during the treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL300 | Biological | CSL300 is a humanized anti-interleukin 6 (anti-IL-6) monoclonal antibody (mAb). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time (AUC) Curve of CSL300 Over 1 Dosing Interval After Multiple Doses (AUC0-tau,MD) | Day 85 up to Day 113 | |
| Trough Concentration at Steady State (Ctrough,ss) | Up to Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interests (AESIs) | The following adverse events (AEs) are defined as AESIs: relevant infections (tuberculosis, herpes simplex virus, herpes zoster, human papillomavirus, human immunodeficiency virus, hepatitis B, hepatitis C, and invasive fungal infections), and demyelinating disorders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | Contact | +16108784697 | clinicaltrials@cslbehring.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D050197 | Atherosclerosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study.
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Sponsor staff will remain unblinded in this study.
| Placebo | Other | Placebo is a solution for injection matching the excipient content and concentration of the CSL300 product, minus the active ingredient. |
|
| Up to Day 225 (End of Study [EoS]) |
| Percentage of Participants With TEAEs, SAEs, and AESIs | The following AEs are defined as AESIs: relevant infections (tuberculosis, herpes simplex virus, herpes zoster, human papillomavirus, human immunodeficiency virus, hepatitis B, hepatitis C, and invasive fungal infections), and demyelinating disorders. | Up to Day 225 (EoS) |
| Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Test Results | Laboratory assessments will include hematology parameters such as white blood cells (leukocytes), neutrophils, and platelets; chemistry evaluations including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin; a lipid panel comprising total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides; and immunogenicity testing. | At Baseline and up to Day 225 (EoS) |
| Number of Participants With Antidrug Antibodies | The detection of antibodies to CSL300 will be performed using a validated immunoassay method. | At Days 1, 29, 85, and 169 |
| Maximum Observed Concentration (Cmax) of CSL300 | Up to Day 169 |
| Area Under the Concentration-Time Curve From Time 0 to Day 28 (AUC0-28d) of CSL300 | Up to Day 28 |
| Trough Concentration (Ctrough) of CSL300 | Up to Day 141 |
| Time to Reach Cmax (Tmax) of CSL300 | Up to Day 85 |
| Change From Baseline on log-scale High-Sensitivity C-reactive Protein (hs-CRP) | At Baseline, Week 12, and Week 24 |
| Plasma Interleukin-6 (IL-6) Free and Total Levels | At Weeks 12 and 24 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |