Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)

• ClinicalTrials.gov Identifier: NCT00794326
• Recruitment Status: Completed
• First Posted: November 20, 2008
• Last Update Posted: February 27, 2015
• Sponsor: Fresenius Medical Care Deutschland GmbH
• Information provided by (Responsible Party): Fresenius Medical Care Deutschland GmbH

Tracking Information

• First Submitted Date: November 18, 2008
• First Posted Date: November 20, 2008
• Last Update Posted Date: February 27, 2015
• Study Start Date: October 2008
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 19, 2008): The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline. [ Time Frame: At the beginning and after 8 weeks of treatment ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00794326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 19, 2008)

• Measurement of Residual Renal Function [ Time Frame: At the beginning, at two and six months of treatment ]
• Follow-up of frequency of hyponatremia, of AE and SAE [ Time Frame: During whole period of the study ]
• Assessment of changes in sodium removal [ Time Frame: At the beginning and at two months of treatment ]
• Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes [ Time Frame: At the beginning, at two and at six months of treatment ]
• Measurement of 24hours peritoneal clearance [ Time Frame: At the beginning and at 2 months of treatment ]
• Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0 [ Time Frame: At the beginning, at two and six months of treatment ]
• Office systolic and diastolic blood pressure measurement during follow up period [ Time Frame: End of treatment, follow-up period ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
• Official Title: Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis
• Brief Summary: The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.

Detailed Description

Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality.

Moreover the poor control of dry weight and sodium/water balance results in increased morbidity. A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid, which allows achieving a negative sodium balance without altering water balance.

The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure and/or medication for hypertension, defined as the primary endpoint.

In order to evaluate the main criteria, blood pressure, a 24hours Ambulatory Blood Pressure Monitoring (ABPM) will be performed twice during the study, at Baseline and at 8 weeks of treatment, according to the EMEA guidance recommendations for anti-hypertensive treatments. In addition, the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension.

The study is designed in three periods:

• Run-in period during 1 month: a reference product Gambrosol Trio 40, one bag/ day will be used by all patients. This period is dedicated to train the patient in using of study product, to stabilize the patient in the PD treatment and to randomize the patient, by performing the 24h ABPM.
• Efficacy & Safety period during 6 months: each patient will be treated with one of two product : PDsol 12 (studied product) or Gambrosol Trio 40 (reference product) during 6 months. The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid.
• Follow-up period during 2 months: without treatment. This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Chronic Kidney Failure

Intervention

Drug: Solution for Peritoneal Dialysis

Treatment with one bag per day during 6 months

Study Arms

• Experimental: PDsol 12
  Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
  Intervention: Drug: Solution for Peritoneal Dialysis
• Active Comparator: Gambrosol trio 40
  Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
  Intervention: Drug: Solution for Peritoneal Dialysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 19, 2008): 140
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Chronic renal failure
• Stable patients on PD treatment
• Treatment at the study site for at least three months
• Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week including at least one with duration of 4-6 hours, and at least one low strength bag per day, or in an APD program with at least one daytime exchange with duration of 4-6 hours using one low strength bag
• Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140 and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication including diuretics, disregarded blood pressure values
• Patients aged 18 years or more
• Written consent to participate in the study (informed consent)
• Able to use a three-compartment bag
• Life expectancy and expected technical survival ≥ 9 months

Exclusion Criteria:

• Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105 mean 24h SBP)
• Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and symptomatic after standing for at least 1 minute
• Natremia < 130 mmol/l, after two consecutive measurements
• Chronic arrhythmia
• Pregnancy or lactation
• Participation in other studies during the study period which may affect the outcome of the present study
• Peritonitis within one month prior to the study start
• Exit site and /or tunnel infection
• Patients unable to tolerate 2 L bag exchanges
• Patients on non-compatible PD system

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, France, Germany, Sweden, United Kingdom
• Removed Location Countries: Portugal

Administrative Information

• NCT Number: NCT00794326
• Other Study ID Numbers: 1449; EudraCT 2007-005365-35
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Fresenius Medical Care Deutschland GmbH
• Study Sponsor: Fresenius Medical Care Deutschland GmbH
• Collaborators: Not Provided

Investigators

• Study Chair: Simon Davies, Prof; University Hospital of North Staffordshire, Stoke-on-Trent, UK
• Study Chair: Bengt Rippe, Prof; Lund University
• Study Chair: Börje Haraldsson, Prof; Sahlgrenska University Hospital, Göteborg, Sweden
• Study Chair: François Vrtovsnik, Prof; Bichat -Claude Bernard Hospital, Paris, France
• Study Chair: Vedat Schwenger, Dr; Universitätsklinik University Hospital, Heidelberg, Germany

• PRS Account: Fresenius Medical Care Deutschland GmbH
• Verification Date: September 2014