Peritoneal DialysisNCT06552546
Pharmacokinetics of Single- and Double-dose Icodextrin
A study testing Icodextrin in people with Peritoneal Dialysis, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Icodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Pharmacokinetics of Single- and Double-dose Icodextrin in Patients on Peritoneal Dialysis
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.
Read the detailed description
Icodextrin is confirmed safe and effective as an alternative osmotic agent by numerous clinical studies. Due to its high molecular weight, icodextrin exerts its effect to enhance ultrafiltration (UF) during long (10~14 hours) dwells through prolonged colloid osmosis across the peritoneal membrane in PD patients. However, the utilization of icodextrin is currently limited to 1 exchange per day in order to avoid plasma accumulation of maltose or other metabolites. Two icodextrin bags per day has been reported to be safely prolong PD technique survival in patients in whom one icodextrin exchange provides insufficient UF. A detailed evaluation of the pharmacokinetics and elimination of icodextrin and metabolites following a single exchange has been reported. However, characterization of the plasma kinetics, metabolism and elimination of double dose icodextrin is not available yet. Therefore, we design the study to provide the pharmacokinetics profile of single- and double-dose icodextrin in patients on peritoneal dialysis. 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.
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.
Icodextrin was quantified in plasma, urine and dialysate by exhaustive hydrolysis of all glucose polymers to glucose using the enzyme amyloglucosidase. Free glucose (determined prior to hydrolysis) was subtracted from the result of hydrolysis to obtain the icodextrin concentration. Maltose (DP2), maltotriose (DP3), maltotetraose (DP4) were individually quantified in blood, spent dialysate and urine (for patients with urine output) using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
- Conditions
- Peritoneal Dialysis
- Being tested
- Icodextrin
- Keywords
- Icodextrin, Pharmacokinetics, Peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcodextrinDrug
Also called Extraneal®，Baxter Healthcare (Guangzhou) Co., Ltd.， Guangzhou，China
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Icodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
The maximum serum concentration of icodextrin that occurs after administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days
Clearance(CL)
Serum icodextrin clearance.
Measured: 14 days
Secondary outcomes (1)
Adverse Events
Any adverse events throughout entirety of study as assessed by physician investigator
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Professor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552546
- Sponsor's protocol ID
- 2024-524
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Single- and Double-dose Icodextrin in Patients on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT06552546
- Acronym / sponsor ID
- 2024-524
- Conditions
- Peritoneal Dialysis
- Keywords
- Icodextrin, Pharmacokinetics, Peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Icodextrin is confirmed safe and effective as an alternative osmotic agent by numerous clinical studies. Due to its high molecular weight, icodextrin exerts its effect to enhance ultrafiltration (UF) during long (10~14 hours) dwells through prolonged colloid osmosis across the peritoneal membrane in PD patients. However, the utilization of icodextrin is currently limited to 1 exchange per day in order to avoid plasma accumulation of maltose or other metabolites. Two icodextrin bags per day has been reported to be safely prolong PD technique survival in patients in whom one icodextrin exchange provides insufficient UF. A detailed evaluation of the pharmacokinetics and elimination of icodextrin and metabolites following a single exchange has been reported. However, characterization of the plasma kinetics, metabolism and elimination of double dose icodextrin is not available yet. Therefore, we design the study to provide the pharmacokinetics profile of single- and double-dose icodextrin in patients on peritoneal dialysis. 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.
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.
Icodextrin was quantified in plasma, urine and dialysate by exhaustive hydrolysis of all glucose polymers to glucose using the enzyme amyloglucosidase. Free glucose (determined prior to hydrolysis) was subtracted from the result of hydrolysis to obtain the icodextrin concentration. Maltose (DP2), maltotriose (DP3), maltotetraose (DP4) were individually quantified in blood, spent dialysate and urine (for patients with urine output) using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SICO(single-dose icodextrin) | Experimental | Drug: IcodextrinEligible 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. |
| DICO(double-dose icodextrin) | Experimental | Drug: IcodextrinEligible 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IcodextrinAlso: Extraneal®，Baxter Healthcare (Guangzhou) Co., Ltd.， Guangzhou，ChinaEligible 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. | Drug | DICO(double-dose icodextrin), SICO(single-dose icodextrin) |
Primary outcome
Peak concentration (Cmax)
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
The maximum serum concentration of icodextrin that occurs after administration.
Peak time (Tmax)
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
Time (hours) to achieve the maximum serum concentration.
Area under the concentration-time curve（AUC）
Time frame: 14 days
AUC based on icodextrin serum concentrations.
Elimination half life（t1/2）
Time frame: 14 days
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.
Clearance(CL)
Time frame: 14 days
Serum icodextrin clearance.
1 secondary outcome
Adverse Events
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Dong, Professor principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Icodextrin in people with Peritoneal Dialysis, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Dong, Professor (+86-13911841538, jie.dong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.