Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)
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| ClinicalTrials.gov Identifier: NCT00794326 |
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Recruitment Status :
Completed
First Posted : November 20, 2008
Last Update Posted : February 27, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Failure | Drug: Solution for Peritoneal Dialysis | Phase 3 |
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 (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PDsol 12
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
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Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months |
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Active Comparator: Gambrosol trio 40
Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
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Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794326
Show 29 study locations
| 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 |
| Responsible Party: | Fresenius Medical Care Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00794326 |
| Other Study ID Numbers: |
1449 EudraCT 2007-005365-35 |
| First Posted: | November 20, 2008 Key Record Dates |
| Last Update Posted: | February 27, 2015 |
| Last Verified: | September 2014 |
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Chronic Kidney Failure Peritoneal Dialysis Low sodium solution Hypertension Total Body Water |
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Renal Insufficiency Kidney Failure, Chronic Kidney Diseases Urologic Diseases |
Renal Insufficiency, Chronic Dialysis Solutions Pharmaceutical Solutions |