Back to resultsSafety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Primary Purpose
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Prismocitrate 18
Sponsored by
About this trial
This is an interventional treatment trial for Regional Citrate Anticoagulation (RCA)
Eligibility Criteria
Inclusion Criteria:
- Patients must be >=18 years of age
- Patients who are candidates for CRRT
- Patients expected to survive for at least 24 hours
- Patients with a contraindication to heparin or an increased risk of hemorrhage
- Patient and/or legally-authorized representative has signed a written informed consent form (ICF) per 21 CFR Part 50.55(e)
Exclusion Criteria:
- Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity
- Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease
- Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score > 10
- Patients with refractory shock and associated lactic acidosis (lactate > 4 mmol/L)
- Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation)
- Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study Screening must have a negative serum beta human chorionic gonadotropic [B-hCG] pregnancy test at Screening)
- Patients who are currently participating in another interventional clinical study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prismocitrate 18
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with symptomatic hypocalcemia
Defined as symptomatic patients (e.g., tetany/spasms, seizures, or cardiac events secondary to a prolonged QT interval), with symptoms deemed attributable to hypocalcemia and with a confirmed systemic ionized calcium < 0.9 mmol/L.
Number of participants with symptomatic hypercalcemia
Defined as symptomatic patients (e.g., changes in mental status not explained by the interventions or underlying conditions or cardiac events secondary to a shortened QT interval), with symptoms deemed attributable to hypercalcemia and with a confirmed systemic ionized calcium > 1.4 mmol/L.
Number of participants with symptomatic citrate accumulation
Defined as symptomatic patients (e.g., refractory acidosis), with symptoms deemed attributable to citrate accumulation and with a systemic total calcium to ionized calcium ratio > 2.5.
Secondary Outcome Measures
Number of participants with Adverse Events related to study product and/or procedure
Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section
Lab measurement for Systemic Ionized Calcium by Time Point
Lab measurement for pH by Time Point
Lab measurement for Base Excess by Time Point
Lab measurement for Serum Bicarbonate by Time Point
Lab measurement for Serum Magnesium by Time Point
Lab measurement for Serum Potassium by Time Point
Lab measurement for Phosphate by Time Point
Lab measurement for Systemic Total Calcium Level by Time Point
Lab measurement for Total to Ionized Calcium Ratio by Time Point
Extracorporeal Circuit Life
Lab measurement for Post-filter Ionized Calcium Levels by Time Point
Number of Adverse Events leading to withdrawal
Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section
Full Information
NCT ID
NCT05399537
First Posted
May 27, 2022
Last Updated
July 12, 2023
Sponsor
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05399537
Brief Title
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Official Title
A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 27, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The objective of this study is to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH). The study period of the patient's CRRT will be up to 10 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prismocitrate 18
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Prismocitrate 18
Intervention Description
Prismocitrate 18 solution will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol/L of blood. A BFR between 100 - 180 mL/min will be advised; a lower BFR can minimize patient citrate exposure, particularly in patients with lower body weight.
Primary Outcome Measure Information:
Title
Number of participants with symptomatic hypocalcemia
Description
Defined as symptomatic patients (e.g., tetany/spasms, seizures, or cardiac events secondary to a prolonged QT interval), with symptoms deemed attributable to hypocalcemia and with a confirmed systemic ionized calcium < 0.9 mmol/L.
Time Frame
Day 1 up to Day 10
Title
Number of participants with symptomatic hypercalcemia
Description
Defined as symptomatic patients (e.g., changes in mental status not explained by the interventions or underlying conditions or cardiac events secondary to a shortened QT interval), with symptoms deemed attributable to hypercalcemia and with a confirmed systemic ionized calcium > 1.4 mmol/L.
Time Frame
Day 1 up to Day 10
Title
Number of participants with symptomatic citrate accumulation
Description
Defined as symptomatic patients (e.g., refractory acidosis), with symptoms deemed attributable to citrate accumulation and with a systemic total calcium to ionized calcium ratio > 2.5.
Time Frame
Day 1 up to Day 10
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events related to study product and/or procedure
Description
Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section
Time Frame
Day 1 up to Day 28
Title
Lab measurement for Systemic Ionized Calcium by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 (1 hour after initiation of CRRT, 1 hour after any Prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to Day 10
Title
Lab measurement for pH by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 (1 hour after initiation of CRRT, 1 hour after any Prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to Day 10
Title
Lab measurement for Base Excess by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 (1 hour after initiation of CRRT, 1 hour after any Prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to Day 10
Title
Lab measurement for Serum Bicarbonate by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 (1 hour after initiation of CRRT, 1 hour after any Prismocitrate dose change until stable) and every 6 hours (i.e., 6, 12, 18, 24) up to Day 10
Title
Lab measurement for Serum Magnesium by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 every 6 hours after initiation of CRRT (i.e., 6, 12, 18, 24) up to Day 10
Title
Lab measurement for Serum Potassium by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 every 6 hours after initiation of CRRT (i.e., 6, 12, 18, 24) up to Day 10
Title
Lab measurement for Phosphate by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 every 12 hours after initiation of CRRT up to Day 10
Title
Lab measurement for Systemic Total Calcium Level by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 every 12 hours after initiation of CRRT up to Day 10
Title
Lab measurement for Total to Ionized Calcium Ratio by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 every 12 hours after initiation of CRRT up to Day 10
Title
Extracorporeal Circuit Life
Time Frame
Day 1 to Day 10
Title
Lab measurement for Post-filter Ionized Calcium Levels by Time Point
Time Frame
Baseline (<=6 hours prior to Day 1 initiation of CRRT); Day 1 (1 hour after initiation of CRRT, 1 hour after any Prismocitrate dose change until stable) and every 6 hours (i.e., 6h, 12h, 18h, 24h) up to Day 10
Title
Number of Adverse Events leading to withdrawal
Description
Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section
Time Frame
Day 1 up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be >=18 years of age
Patients who are candidates for CRRT
Patients expected to survive for at least 24 hours
Patients with a contraindication to heparin or an increased risk of hemorrhage
Patient and/or legally-authorized representative has signed a written informed consent form (ICF) per 21 CFR Part 50.55(e)
Exclusion Criteria:
Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity
Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease
Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score > 10
Patients with refractory shock and associated lactic acidosis (lactate > 4 mmol/L)
Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation)
Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study Screening must have a negative serum beta human chorionic gonadotropic [B-hCG] pregnancy test at Screening)
Patients who are currently participating in another interventional clinical study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baxter Clinical Trials Disclosure Call Center
Phone
(224) 948-7359
Email
trials@Baxter.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
IPD Sharing Time Frame
Upon approval of a legitimate research request.
IPD Sharing Access Criteria
Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data
IPD Sharing URL
https://www.baxter.com/clinical-trial-transparency-and-data-sharing-policy
Learn more about this trial
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
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