Clinical trial NCT00794326: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Failure
Keywords: Chronic Kidney Failure
Peritoneal Dialysis
Low sodium solution
Hypertension
Total Body Water
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2008-11-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: At the beginning and after 8 weeks of treatment
Secondary outcomes:
measure: Measurement of Residual Renal Function
timeFrame: At the beginning, at two and six months of treatment
measure: Follow-up of frequency of hyponatremia, of AE and SAE
timeFrame: During whole period of the study
measure: Assessment of changes in sodium removal
timeFrame: At the beginning and at two months of treatment
measure: Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
timeFrame: At the beginning, at two and at six months of treatment
measure: Measurement of 24hours peritoneal clearance
timeFrame: At the beginning and at 2 months of treatment
measure: Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
timeFrame: At the beginning, at two and six months of treatment
measure: Office systolic and diastolic blood pressure measurement during follow up period
timeFrame: End of treatment, follow-up period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Besançon
country: France
facility: CHU Saint-Jacques
city: Caen
country: France
facility: CHRU
city: Chambery
country: France
facility: Hospital of Chambéry
city: Colmar
country: France
facility: CH Colmar
city: Irigny
country: France
facility: Calydial Dialysis Center
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
city: Reims
country: France
facility: ARPDD
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Hannover
country: Germany
facility: KfH-Nierenzentrum am Krankenhaus Oststadt
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
city: Köln
country: Germany
facility: KfH-Nierenzentrum
city: Offenburg
country: Germany
facility: Nephrology center Offenburg
city: Passau
country: Germany
facility: KfH-Nierenzentrum
city: Stuttgart
country: Germany
facility: PHV - Nephrologisches Zentrum Stuttgart
city: Trier
country: Germany
facility: KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
city: Borås
country: Sweden
facility: Södra Älvborgsläns Hospital
city: Göteborg
country: Sweden
facility: University Hospital of Sahlgrenska
city: Lund
country: Sweden
facility: University Hospital of Lund
city: Malmö
country: Sweden
facility: University Hospital of Malmö
city: Skövde
country: Sweden
facility: Skarborgs Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Trollhättan
country: Sweden
facility: Norra Älvsborgs Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: London
country: United Kingdom
facility: The Royal London Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Stoke on Trent
country: United Kingdom
facility: University of North Staffordshire - Renal Medicine - Royal Infirmary
city: Wolverhampton
country: United Kingdom
facility: Wolverhampton New Cross Hospital
Study officials:
affiliation: University Hospital of North Staffordshire, Stoke-on-Trent, UK
name: Simon Davies, Prof
role: STUDY_CHAIR
affiliation: Lund University
name: Bengt Rippe, Prof
role: STUDY_CHAIR
affiliation: Sahlgrenska University Hospital, Göteborg, Sweden
name: Börje Haraldsson, Prof
role: STUDY_CHAIR
affiliation: Bichat -Claude Bernard Hospital, Paris, France
name: François Vrtovsnik, Prof
role: STUDY_CHAIR
affiliation: Universitätsklinik University Hospital, Heidelberg, Germany
name: Vedat Schwenger, Dr
role: STUDY_CHAIR
References: