End Stage Renal DiseasePhase 2NCT01242904
Use of a Bimodal Solution for Peritoneal Dialysis
A Phase 2 study testing bimodal solution and icodextrin in people with End Stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000 end stage renal disease patients worldwide to help replace the functions that are no longer performed by their kidneys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- bimodal solution and icodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2010to 28 Feb 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to provide informed consent
- Age greater than 18 years
- Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks
- Be APD patients who;
- Can be managed with an icodextrin long dwell AND
- Will use 4.25% and/or a 2.5% solution for at least one exchange overnight in at least 5 out of 7 days
- Have residual urine volume <800 ml/24 hours
- Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.
Who cannot join
- Scheduled Transplant in the next 1 year
- Life expectancy < 3 mo (estimated by physician)
- Participating in other trial that could influence outcome of this trial
- Known icodextrin allergy
- Currently using non-Baxter PD solutions
- Systolic blood pressure < 90 mm Hg on more than three occasions during a seven day period, despite discontinuation of non-essential anti-hypertensives
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- Supplementary Exclusion Criteria (post Run-in phase):
- 1) Unsuccessfully completed 1 week run-in phase. Defined as:
- Not using bimodal solution on 7 consecutive days during the run-in
- Not tolerating the increased UF anticipated with the bimodal solution. Tolerating defined as:
- Blood pressure drop below 90/50 on more than three occasions during a seven day period that cannot be corrected by reducing anti-hypertensives or other simple measures ii) Intolerable feeling of fullness with the bimodal solution iii) Allergic reaction (although all patients have already been exposed to icodextrin)
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit
London, Ontario, N6A 5W9
About this study
Official title: Randomized Controlled Trial of Bimodal Solution for Peritoneal Dialysis: 24-Hour UF Efficiency Using Bimodal PD Solutions During the Long Dwell
Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000 end stage renal disease patients worldwide to help replace the functions that are no longer performed by their kidneys. An important advantage of PD is it offers an alternative to hemodialysis that can be safely performed by patients in their own homes. In PD, the peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of solutes and water between the membrane capillaries and a dialysis solution that is infused into the peritoneal cavity. PD dialysis solutions typically require high concentrations of glucose to adequately perform these functions. Over time the continued exposure of the peritoneal membrane to high concentrations of glucose can permanently damage the membrane. Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that does not harm the peritoneal membrane. However, its use can lead to inadequate fluid removal. Recent research has focused on finding a PD solution, or combination of solutions, that will maximize the removal of toxic substances and metabolites while maintaining regulation of fluid and electrolyte balance in the body. A bimodal solution that combines glucose and icodextrin has been shown in observational studies to be effective and safe. The investigators propose a randomized, controlled, blinded study that will determine the effectiveness and safety of this bimodal fluid in a Canadian PD population. The investigators hypothesize that the use of the bimodal solution during the long (day) dwell will lead to an improvement in 24 hour ultrafiltration efficiency as compared to usual care using icodextrin for the long dwell.
- Conditions
- End Stage Renal Disease
- Being tested
- bimodal solution, icodextrin
- Keywords
- dialysis solutions, renal replacement therapy, peritoneal dialysis, bimodal solution, glucose sparing therapy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimodal solutionDrug
200 mL of 30% glucose infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler
icodextrinDrug
200 mL of icodextrin infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler
| Study group | Role | What they receive |
|---|---|---|
| bimodal solution | Experimental | 200 mls of 30% glucose in sterile water is added by the patient to the usual icodextrin day dwell, to create the bimodal solution intraperitoneally Receives: Drug: bimodal solution |
| icodextrin | Active comparator | 200 mls of icodextrin is added by the patient to the usual icodextrin day dwell Receives: Drug: icodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
net ultrafiltration efficiency in mL/g
Ultrafiltration Efficiency (UFE): UFE is defined as the amount of 24 hour net Ultrafiltration (UF) obtained for every gram of carbohydrate absorbed from the dialysis solution.
- 24-hour net ultrafiltration (in mL) is recorded automatically by the Automated Peritoneal Dialysis (APD) cycler.
- Carbohydrate absorption is determined by calculating the difference (in grams) between the amount of glucose (measured by lab analysis) in the 24 hr peritoneal effluent, and the amount of glucose in the patient's dialysis prescription.
- UFE will be calculated in mL/g (ie a divided by b)
Measured: Calculated at baseline and at the end of the 6 week intervention period
Secondary outcomes (9)
24-hour absolute total carbohydrate absorption
This will include both glucose and icodextrin absorption.
Measured: Calculated at baseline and at the end of the 6 week intervention period
24-hour urine volume
Measured: Calculated at baseline and at the end of the 6 week intervention period
24-hour net sodium removal (in both peritoneal effluent and urine)
Measured: Calculated at baseline and at the end of the 6 week intervention period
Volume measures as calculated by bioimpedance analysis
Measured: Calculated at baseline and at the end of the 6 week intervention period
Weight
Used as an indicator of fluid retention
Measured: Calculated at baseline and at the end of the 6 week intervention period
Mean and pulse arterial pressure
Measured: Calculated at baseline and at the end of the 6 week intervention period
Number of anti-hypertensive agents
Measured: Calculated at baseline and at the end of the 6 week intervention period
Renal (urine) solute clearance (Sodium, Urea, Creatinine)
Measured: Calculated at baseline and at the end of the 6 week intervention period
Peritoneal effluent solute clearance (Sodium, Urea, Creatinine)
Measured: Calculated at baseline and at the end of the 6 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study start30 Sep 2010
- Primary completion28 Feb 2015
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Arsh K Jain, MD, Principal investigator, London Health Sciences Centre, Dept of Medicine, Victoria Campus, London Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242904
- Sponsor's protocol ID
- R-10-460
- Other IDs
- 17193
- Status last verified
- Aug 2017
- First submitted
- 16 Nov 2010
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Bimodal Solution for Peritoneal Dialysis: 24-Hour UF Efficiency Using Bimodal PD Solutions During the Long Dwell
- ClinicalTrials.gov ID
- NCT01242904
- Acronym / sponsor ID
- R-10-460
- Conditions
- End Stage Renal Disease
- Keywords
- dialysis solutions, renal replacement therapy, peritoneal dialysis, bimodal solution, glucose sparing therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 17 Nov 2010 (estimated)
- 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.
Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000 end stage renal disease patients worldwide to help replace the functions that are no longer performed by their kidneys. An important advantage of PD is it offers an alternative to hemodialysis that can be safely performed by patients in their own homes. In PD, the peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of solutes and water between the membrane capillaries and a dialysis solution that is infused into the peritoneal cavity. PD dialysis solutions typically require high concentrations of glucose to adequately perform these functions. Over time the continued exposure of the peritoneal membrane to high concentrations of glucose can permanently damage the membrane. Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that does not harm the peritoneal membrane. However, its use can lead to inadequate fluid removal. Recent research has focused on finding a PD solution, or combination of solutions, that will maximize the removal of toxic substances and metabolites while maintaining regulation of fluid and electrolyte balance in the body. A bimodal solution that combines glucose and icodextrin has been shown in observational studies to be effective and safe. The investigators propose a randomized, controlled, blinded study that will determine the effectiveness and safety of this bimodal fluid in a Canadian PD population. The investigators hypothesize that the use of the bimodal solution during the long (day) dwell will lead to an improvement in 24 hour ultrafiltration efficiency as compared to usual care using icodextrin for the long dwell.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bimodal solution | Experimental | Drug: bimodal solution200 mls of 30% glucose in sterile water is added by the patient to the usual icodextrin day dwell, to create the bimodal solution intraperitoneally |
| icodextrin | Active comparator | Drug: icodextrin200 mls of icodextrin is added by the patient to the usual icodextrin day dwell |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be able to provide informed consent
- Age greater than 18 years
- Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks
- Be APD patients who;
- Have residual urine volume <800 ml/24 hours
Key exclusion criteria (11 listed)
- Scheduled Transplant in the next 1 year
- Life expectancy < 3 mo (estimated by physician)
- Participating in other trial that could influence outcome of this trial
- Known icodextrin allergy
- Currently using non-Baxter PD solutions
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 |
|---|---|---|
| bimodal solution200 mL of 30% glucose infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler | Drug | bimodal solution |
| icodextrin200 mL of icodextrin infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler | Drug | icodextrin |
Primary outcome
net ultrafiltration efficiency in mL/g
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Ultrafiltration Efficiency (UFE): UFE is defined as the amount of 24 hour net Ultrafiltration (UF) obtained for every gram of carbohydrate absorbed from the dialysis solution. 1. 24-hour net ultrafiltration (in mL) is recorded automatically by the Automated Peritoneal Dialysis (APD) cycler. 2. Carbohydrate absorption is determined by calculating the difference (in grams) between the amount of glucose (measured by lab analysis) in the 24 hr peritoneal effluent, and the amount of glucose in the patient's dialysis prescription. 3. UFE will be calculated in mL/g (ie a divided by b)
9 secondary outcomes
24-hour absolute total carbohydrate absorption
Time frame: Calculated at baseline and at the end of the 6 week intervention period
24-hour urine volume
Time frame: Calculated at baseline and at the end of the 6 week intervention period
24-hour net sodium removal (in both peritoneal effluent and urine)
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Volume measures as calculated by bioimpedance analysis
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Weight
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Mean and pulse arterial pressure
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Number of anti-hypertensive agents
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Renal (urine) solute clearance (Sodium, Urea, Creatinine)
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Peritoneal effluent solute clearance (Sodium, Urea, Creatinine)
Time frame: Calculated at baseline and at the end of the 6 week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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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.
Arsh K Jain, MD principal investigator
London Health Sciences Centre, Dept of Medicine, Victoria Campus, London Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bimodal solution and icodextrin in people with End Stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 28 Aug 2017. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
net ultrafiltration efficiency in mL/g (time frame: Calculated at baseline and at the end of the 6 week intervention period). 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 28 Aug 2017.