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Use of a Bimodal Solution for Peritoneal Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01242904
First received: November 16, 2010
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Drug: bimodal solution
Drug: icodextrin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Bimodal Solution for Peritoneal Dialysis: 24-Hour UF Efficiency Using Bimodal PD Solutions During the Long Dwell

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • net ultrafiltration efficiency in mL/g [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • 24-hour absolute total carbohydrate absorption [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
    This will include both glucose and icodextrin absorption.

  • 24-hour urine volume [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Volume measures as calculated by bioimpedance analysis [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
    Used as an indicator of fluid retention

  • Mean and pulse arterial pressure [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
  • Number of anti-hypertensive agents [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
  • Renal (urine) solute clearance (Sodium, Urea, Creatinine) [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]
  • Peritoneal effluent solute clearance (Sodium, Urea, Creatinine) [ Time Frame: Calculated at baseline and at the end of the 6 week intervention period ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bimodal solution
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
Drug: bimodal solution
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
Active Comparator: icodextrin
200 mls of icodextrin is added by the patient to the usual icodextrin day dwell
Drug: icodextrin
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be able to provide informed consent
  2. Age greater than 18 years
  3. Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks
  4. Be APD patients who;

    1. Can be managed with an icodextrin long dwell AND
    2. Will use 4.25% and/or a 2.5% solution for at least one exchange overnight in at least 5 out of 7 days
  5. Have residual urine volume <800 ml/24 hours
  6. Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.

Exclusion Criteria:

  1. Scheduled Transplant in the next 1 year
  2. Life expectancy < 3 mo (estimated by physician)
  3. Participating in other trial that could influence outcome of this trial
  4. Known icodextrin allergy
  5. Currently using non-Baxter PD solutions
  6. Systolic blood pressure < 90 mm Hg on more than three occasions during a seven day period, despite discontinuation of non-essential anti-hypertensives

Supplementary Exclusion Criteria (post Run-in phase):

1) Unsuccessfully completed 1 week run-in phase. Defined as:

  1. Not using bimodal solution on 7 consecutive days during the run-in
  2. Not tolerating the increased UF anticipated with the bimodal solution. Tolerating defined as:

i) 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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242904

Contacts
Contact: Lenora Perry, BHSc(hons) 1-(519)-685-8500 ext 55975 lenora.perry@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre, South Street Hospital, Peritoneal Dialysis Unit Recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Arsh K Jain, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Baxter Healthcare Corporation
Investigators
Principal Investigator: Arsh K Jain, MD London Health Sciences Centre, Dept of Medicine, Victoria Campus, London Ontario
  More Information

No publications provided

Responsible Party: Arsh Jain/MD, London Health Sciences Centre, Dept of Medicine, Division of Nephrology
ClinicalTrials.gov Identifier: NCT01242904     History of Changes
Other Study ID Numbers: R-10-460, 17193
Study First Received: November 16, 2010
Last Updated: August 3, 2011
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
dialysis solutions
renal replacement therapy
peritoneal dialysis
bimodal solution
glucose sparing therapy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Icodextrin
Pharmaceutical Solutions
Dialysis Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014