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Pharmacokinetics of Single- and Double-dose Icodextrin

ConditionPeritoneal Dialysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: SICO(single-dose icodextrin)Experimental treatment 1 intervention
Group B: DICO(double-dose icodextrin)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Peak concentration (Cmax)

The maximum serum concentration of icodextrin that occurs after administration.

Time frame
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
2

Peak time (Tmax)

Time (hours) to achieve the maximum serum concentration.

Time frame
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
3

Area under the concentration-time curve（AUC）

AUC based on icodextrin serum concentrations.

Time frame
14 days
4

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.

Time frame
14 days

Secondary outcomes

1

Adverse Events

Any adverse events throughout entirety of study as assessed by physician investigator

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: