Pharmacokinetics of Single- and Double-dose Icodextrin

NCT06552546 | Not Yet Recruiting

• 1 other identifier: 2024-524
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to provide the pharmacokinetics profiles of single- and double-dose icodextrin in patients on peritoneal dialysis (PD). It may expand the available knowledge of the clinical pharmacology of icodextrin following its intraperitoneal administration and fills the gaps in our understanding of the fate of icodextrin and the metabolic consequences of icodextrin and its metabolites.

Conditions

Peritoneal Dialysis

Keywords

Icodextrin; Pharmacokinetics; Peritoneal dialysis

Outcome Measures

Primary Outcomes (5)

• Peak concentration (Cmax)

  The maximum serum concentration of icodextrin that occurs after administration.

  SICO: 0, 4, 8, 10, 12,16, 20, 24, 48, 72 hour, and day 7 and 14; DICO: 0, 4, 8, 12,16, 18, 20, 24, 28, 32, 56, 80 hour and day 7 and 14

• Peak time (Tmax)

  Time (hours) to achieve the maximum serum concentration.

  SICO: 0, 4, 8, 10, 12,16, 20, 24, 48, 72 hour, and day 7 and 14; DICO: 0, 4, 8, 12,16, 18, 20, 24, 28, 32, 56, 80 hour and day 7 and 14

• Area under the concentration-time curve（AUC）

  AUC based on icodextrin serum concentrations.

  14 days

• Elimination half life（t1/2）

  How long it takes for blood levels to drop by half. This parameter directly reflects the rate at which the drug is eliminated from the body.

  14 days

• Clearance(CL)

  Serum icodextrin clearance.

  14 days

Secondary Outcomes (1)

• Adverse Events

  14 days

Study Arms (2)

SICO(single-dose icodextrin)

EXPERIMENTAL

Eligible participants used one icodextrin bag (single-dose icodextrin, SICO) on the first day. Icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. After the icodextrin exchange, the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of single-dose icodextrin were provided.

Drug: Icodextrin

DICO(double-dose icodextrin)

EXPERIMENTAL

Eligible participants used two icodextrin bags (double-dose icodextrin, DICO) on the first day. Each icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. The double-dose icodextrin was administered in a sequential way. After the icodextrin exchange, the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of double-dose icodextrin were provided.

Drug: Icodextrin

Interventions

Icodextrin DRUG

Eligible participants were admitted to the hosptial ward and used one icodextrin bag (single-dose icodextrin) or two icodextrin bags (double-dose icodextrin) on the first day, depending on their choice. Each icodextrin solution was left in the peritoneal cavity for a 8-hour dwell. The double-dose icodextrin was administered in a sequential way. After the icodextrin exchange(s), the solution was drained from the peritoneal cavity and the patients resumed dialysis using dextrose dialysate with two or three additional manual exchanges performed for the balance of the 24 hours since the icodextrin dwell was initiated. Patients were discharged and requested to return on days 7 and 14. Blood, urine and dialysate samples are collected at the time-points as required. Icodextrin and metabolites were analyzed and the pharmacokinetics profiles of single- and double-dose icodextrin were provided.

Also known as: Extraneal®，Baxter Healthcare (Guangzhou) Co., Ltd.， Guangzhou，China

DICO(double-dose icodextrin); SICO(single-dose icodextrin)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end stage renal disease, receiving peritoneal dialysis for \> 3 months, and clinically stable.
• Suitable for 4 exchanges of manual peritoneal dialysis on the first study day.

You may not qualify if:

• History of allergic reaction to icodextrin dialysis solution or corn starch;
• With malignant tumor receiving radiotherapy and/or chemotherapy, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating disorder, or HIV/AIDS;
• Acute systemic infection, peritonitis, catheter-related infection, cardiovascular disease, surgery, or trauma in the previous one month;
• A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 1 months;
• Receiving hybrid dialysis (peritoneal dialysis combined with hemodialysis);
• Pregnant or lactating female;
• Having used icodextrin within previous 30 days；
• Peritoneal catheter dysfunction；
• Not suitable for enrollment assessed by researchers, including those unable followed the study protocol, or enrolled in other intervention studies, or with other reasons considering not suitable for enrollment by researchers.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Interventions

Icodextrin

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Jie Dong, Professor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Dong, Professor

CONTACT

+86-13911841538; jie.dong@bjmu.edu.cn

Zhikai Yang, Doctor

CONTACT

+86-13671248465; seapollar@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 14, 2024
• Study Start: August 15, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)