Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis
NCT ID: NCT05721404
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
194 participants
INTERVENTIONAL
2023-05-24
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* The effect of icodextrin on the shift of low dose to full dose dialysis in the first year in patients on incremental peritoneal dialysis.
* The effect of icodextrin on clinical outcomes in patients on incremental peritoneal dialysis, such as the first episode of peritonitis, the incidence of anuria, the first incidence of hospitalization, technical failure, all cause mortality, cardiovascular disease free survival and the quality of life.
Participants will be 1:1 randomized to the ICO (icodextrin) arm and CON (control) arm. Both arms patients will be followed every 2 months for fluid status by bioimpedance analysis. An extracellular water /total body water (ECW/TBW) ≥ 0.40 or edema is defined as overhydration (OH). The OH patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW \< 0.40 or edema disappeared. The OH patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW \< 0.40 or edema disappeared.
Researchers will compare the time of transferring from low dose PD to full dose and the clinical outcomes in the first year between the patients in ICO and CON groups to see the effect of icodextrin on the shift of low dose to full dose dialysis and clinical outcomes in the first year in patients on incremental peritoneal dialysis. Successful completion of the study will advance our strategy of incremental PD and help to prolong the shift from incremental to full dose dialysis, and offer new opportunities for the development of an effective and economical therapy for PD patients with residual kidney function (RKF)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
NCT06492031
Incremental PD With Single Icodextrin Exchange
NCT06119373
The Difference Between Daily and Alternative Day Use of Icodextrin
NCT05943470
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
NCT01044446
Pharmacokinetics of Single- and Double-dose Icodextrin
NCT06552546
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The objective of this study is to investigate the effects of icodextrin on postponing the shift of lowdose at the initial dialysis to full dose dialysis in the first year of PD in patients with incremental PD. The specific details of treatment/intervention are as follow:
1. Incident PD patients of SYSU PD center who meet the inclusion criteria will be recruited. All participants will be 1:1 randomized to the ICO (icodextrin) arm and CON (control) arm. Day 0 was defined as 6 weeks ± 4 weeks after CAPD initiation.
2. The patients in both the ICO and CON arms are prescribed Dextrose 2 L x 3 for incremental peritoneal dialysis during the first year.
3. Both arms patients will be followed every 2 months for fluid status by bioimpedance analysis (BIA). An extracellular water /total body water (ECW/TBW) ≥ 0.40 is defined as overhydration (OH).
4. The OH patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW \< 0.40 or edema disappeared. The OH patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW \< 0.40 or edema disappeared. This means that all the patients in both arms will use the same three bags of glucose solution per day at the beginning of the study. When patients have overhydration \[(ECW/TBW) ≥ 0.4 or edema\], the long night dwell glucose solution in the ICO group will be replaced by Icodextrin till ECW/TBW \< 0.40 or edema disappeared. While patients with overhydration in the CON group will increase glucose concentration till their ECW/TBW \< 0.40 or edema disappeared. (The advantage of icodextrin has been proven in patients with ultrafiltration failure, high transport peritoneal membranes, and diabetics as compared to standard glucose based dialysate.
5. Both arms patients will be followed every 2 months for clinical manifestations, medication, and PD prescription (PD modality, dosage, and dialysate glucose concentration) during routine visits.
6. Patients in the both arms will be transferred to full dose dialysis if they have the following clinical manifestations: refractory fluid overload, unexplained nausea or vomiting, hyperkalemia, metabolic acidosis, uncontrollable hyperphosphatemia, uremia, neuropathy, pericarditis, sleep disorder, restless legs syndrome, pruritus, intractable anemia.
7. If necessary, medications will be used for treatment of hypertension, anaemia, chronic kidney disease-mineral and bone disorder, malnutrition, hyperlipidemia, the acid-base imbalance, electrolyte disturbance, etc.
8. If heart failure happened, patients in both the ICO and CON arms will be performed intermittent PD (IPD).
Efficacy Assessments:
1. Baseline data and follow-up information will be collected. Baseline demographics includes age, sex, primary kidney disease, body mass index (BMI), and diabetes. Baseline laboratory data include GFR, creatinine clearance (CrCl), urea clearance weekly (Kt/Vurea), ultrafiltration volume, systolic blood pressure (SBP), diastolic blood pressure (DBP), 24-h urine volume, serum albumin, serum creatinine (Scr), blood urea nitrogen (BUN), uric acid (UA), hemoglobin, intact parathyroid hormone (iPTH), total cholesterol, triglycerides, calcium, and phosphorus.
2. Both 24-hour urine and PD effluent will be collected at the same time each day to calculate Kt/Vurea, creatinine clearance, normalized protein clearance rate, and measured GFR using Adequest 2.0 software (Baxter Healthcare).
3. The adequacy of renal and peritoneal solute clearance will be assessed by total weekly Kt/V calculated using standard methodology. CAPD patients will receive Kt/V test every 2-4 months.
4. Peritoneal function and biomarkers for peritoneal biocompatibility will be performed: the peritoneal equilibration test (PET), sodium dip, CA125 and interleukin- 6 (IL-6) in effluent of patients in both groups.
5. All baseline data will be collected at day 0. Both arms patients will be followed up every 2 months for clinical manifestations, medication, and PD prescription (PD modality, dosage, and dialysate glucose concentration) during routine visits.
6. Events such as the episodes of peritonitis, transferring to hemodialysis (HD), anuria, cardiovascular disease(CVD), hospitalization, all cause death and CVD death will be recorded.
7. Quality of Life (Medical Outcomes Study 36-Item Short From Survey) will be measured and collected at the Day 0 and at the end of the study.
Statistical Methods:
1. Sample size:
A preliminary analysis using database of our PD center showed: A total of 193 subjects (of which 97 are in group1 and 96 are in group 2) achieves 80% power at a 0.0500 significance level to detect a difference of 0.1900 between 0.6200 and 0.8100--the proportions surviving in groups 1 and 2, respectively. This corresponds to a hazard ratio of 0.4408. The proportion of patients lost during follow up was 0.0500. These results are based on the assumption that the hazard rates are proportional. Accordingly, 194 subjects (97 in each group) were intended to be included in the study.
2. Primary Endpoint Analysis:
Primary endpoint (event that transferring from a low dose dialysis to full dose dialysis in the first year of incremental PD) analyses are on the basis of the intent-to-treat approach. Patient event-free survival will be calculated using the Kaplan-Meier method, and differences between different groups are assessed by log-rank tests. Considering patients transferred to other modalities as censoring (competing end points), the Fine and Gray proportional subhazards model will be used to create a competing risk model.
3. Secondary endpoint(s) analysis:
Secondary endpoints include first episode of peritonitis, anuria, CVD free survival, first hospitalization, technique failure (transferring to HD), all-cause and cardiovascular mortality, which will be evaluating using the Kaplan-Meier method, and differences between different groups are assessed by log-rank tests. Considering patients transferred to other modalities as censoring (competing end points), the Fine and Gray proportional subhazards model will be used to create a competing risk model. Quality of Life (PF, RP, BP, GH, VT, SF, RE, MH, PCS, MCS, total score of SF-36) will be evaluated using an unpaired Student's t test or Mann-Whitney U test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ICO (icodextrin)
When the extracellular water /total body water (ECW/TBW) ≥ 0.40, the patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW \< 0.40.
Icodextrin Peritoneal Dialysis Solution
Icodextrin (Extraneal) for long night dwell
CON (control)
When the extracellular water /total body water (ECW/TBW) ≥ 0.40, the patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW \< 0.40
Hypertonic Dextrose solution
Hypertonic Dextrose solution for long night dwell
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Icodextrin Peritoneal Dialysis Solution
Icodextrin (Extraneal) for long night dwell
Hypertonic Dextrose solution
Hypertonic Dextrose solution for long night dwell
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The estimated glomerular filtration rate (eGFR) ≥ 3ml/min·1.73m2 when enrolled;
* The 24-hour urine volume ≥ 500ml when enrolled;
* The patient or his lawful representative is able to receive and complete training of home peritoneal dialysis;
* Patients were able to follow the follow-up schedule and other requirements of the study;
* Patients can come to the peritoneal dialysis center for regular follow-up (once every 2 months or more);
* Participants were expected to remain on peritoneal dialysis for at least 13 months;
* Patients with good compliance;
* Informed consent was obtained.
Exclusion Criteria
* Patients who have previously received a kidney transplant and have been receiving immunosuppressive therapy;
* Contraindications to bioelectrical impedance analysis (BIA) testing (e.g., amputation, use of a pacemaker or prosthesis);
* Allergy to Icodextrin, starch and starch products, or suffer from glycogen storage disease;
* Contraindications for the use of icodextrin;
* HIV-positive participants;
* Patients with tumors or other serious diseases have a life expectancy of less than one year;
* Mental illness that interferes with the patient's understanding of the test requirements and completion of the test process;
* Chronic wasting diseases such as tuberculosis, cirrhosis, hematological or other malignancies;
* Patients who are pregnant, intending to become pregnant, or breastfeeding during the study period;
* The patients had a history of drug abuse or alcoholism 2 years before the screening period;
* Patients who are unwilling or not expected to fully comply with the visits and evaluations required by the protocol;
* Patients who, in the investigator's judgment, have other serious or acute medical conditions that may prevent them from participating in the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baxter Healthcare Corporation
INDUSTRY
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiao Yang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiao Yang, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Thomas B, Wulf S, Bikbov B, Perico N, Cortinovis M, Courville de Vaccaro K, Flaxman A, Peterson H, Delossantos A, Haring D, Mehrotra R, Himmelfarb J, Remuzzi G, Murray C, Naghavi M. Maintenance Dialysis throughout the World in Years 1990 and 2010. J Am Soc Nephrol. 2015 Nov;26(11):2621-33. doi: 10.1681/ASN.2014101017. Epub 2015 Jul 24.
Brown EA, Blake PG, Boudville N, Davies S, de Arteaga J, Dong J, Finkelstein F, Foo M, Hurst H, Johnson DW, Johnson M, Liew A, Moraes T, Perl J, Shroff R, Teitelbaum I, Wang AY, Warady B. International Society for Peritoneal Dialysis practice recommendations: Prescribing high-quality goal-directed peritoneal dialysis. Perit Dial Int. 2020 May;40(3):244-253. doi: 10.1177/0896860819895364. Epub 2020 Jan 21. No abstract available.
Lee Y, Chung SW, Park S, Ryu H, Lee H, Kim DK, Joo KW, Ahn C, Lee J, Oh KH. Incremental Peritoneal Dialysis May be Beneficial for Preserving Residual Renal Function Compared to Full-dose Peritoneal Dialysis. Sci Rep. 2019 Jul 12;9(1):10105. doi: 10.1038/s41598-019-46654-2.
Sandrini M, Vizzardi V, Valerio F, Ravera S, Manili L, Zubani R, Lucca BJ, Cancarini G. Incremental peritoneal dialysis: a 10 year single-centre experience. J Nephrol. 2016 Dec;29(6):871-879. doi: 10.1007/s40620-016-0344-z. Epub 2016 Aug 31.
Ankawi GA, Woodcock NI, Jain AK, Garg AX, Blake PG. The Use of Incremental Peritoneal Dialysis in a Large Contemporary Peritoneal Dialysis Program. Can J Kidney Health Dis. 2016 Dec 13;3:2054358116679131. doi: 10.1177/2054358116679131. eCollection 2016.
Yan H, Fang W, Lin A, Cao L, Ni Z, Qian J. Three Versus 4 Daily Exchanges and Residual Kidney Function Decline in Incident CAPD Patients: A Randomized Controlled Trial. Am J Kidney Dis. 2017 Apr;69(4):506-513. doi: 10.1053/j.ajkd.2016.08.019. Epub 2016 Oct 15.
Garofalo C, Borrelli S, De Stefano T, Provenzano M, Andreucci M, Cabiddu G, La Milia V, Vizzardi V, Sandrini M, Cancarini G, Cupisti A, Bellizzi V, Russo R, Chiodini P, Minutolo R, Conte G, De Nicola L. Incremental dialysis in ESRD: systematic review and meta-analysis. J Nephrol. 2019 Oct;32(5):823-836. doi: 10.1007/s40620-018-00577-9. Epub 2019 Jan 2.
Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.
Guo Q, Yi C, Li J, Wu X, Yang X, Yu X. Prevalence and risk factors of fluid overload in Southern Chinese continuous ambulatory peritoneal dialysis patients. PLoS One. 2013;8(1):e53294. doi: 10.1371/journal.pone.0053294. Epub 2013 Jan 14.
Guo Q, Lin J, Li J, Yi C, Mao H, Yang X, Yu X. The Effect of Fluid Overload on Clinical Outcome in Southern Chinese Patients Undergoing Continuous Ambulatory Peritoneal Dialysis. Perit Dial Int. 2015 Dec;35(7):691-702. doi: 10.3747/pdi.2014.00008. Epub 2015 Jul 7.
Agar BU, Sloand JA. Single Daily Icodextrin Exchange as Initial and Solitary Therapy. Perit Dial Int. 2018 Mar-Apr;38(2):119-124. doi: 10.3747/pdi.2017.00130. Epub 2018 Jan 31.
Goossen K, Becker M, Marshall MR, Buhn S, Breuing J, Firanek CA, Hess S, Nariai H, Sloand JA, Yao Q, Chang TI, Chen J, Paniagua R, Takatori Y, Wada J, Pieper D. Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Kidney Dis. 2020 Jun;75(6):830-846. doi: 10.1053/j.ajkd.2019.10.004. Epub 2020 Feb 4.
Guest S, Leypoldt JK, Cassin M, Schreiber M. Kinetic Modeling of Incremental Ambulatory Peritoneal Dialysis Exchanges. Perit Dial Int. 2017 Mar-Apr;37(2):205-211. doi: 10.3747/pdi.2016.00055. Epub 2017 Jan 17.
Boateng EA, East L. The impact of dialysis modality on quality of life: a systematic review. J Ren Care. 2011 Dec;37(4):190-200. doi: 10.1111/j.1755-6686.2011.00244.x.
Davies SJ, Phillips L, Griffiths AM, Russell LH, Naish PF, Russell GI. What really happens to people on long-term peritoneal dialysis? Kidney Int. 1998 Dec;54(6):2207-17. doi: 10.1046/j.1523-1755.1998.00180.x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
[2022]042
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.