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

NCT ID: NCT00794326

Last Updated: 2015-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-12-31

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.

Conditions

Chronic Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PDsol 12

Treatment with a peritoneal dialysis solution containing a low concentration of sodium.

Group Type: EXPERIMENTAL

Solution for Peritoneal Dialysis

Intervention Type: DRUG

Treatment with one bag per day during 6 months

Gambrosol trio 40

Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)

Group Type: ACTIVE_COMPARATOR

Solution for Peritoneal Dialysis

Intervention Type: DRUG

Treatment with one bag per day during 6 months

Interventions

Solution for Peritoneal Dialysis

Treatment with one bag per day during 6 months

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Davies, Prof

Role: STUDY_CHAIR

University Hospital of North Staffordshire, Stoke-on-Trent, UK

Bengt Rippe, Prof

Role: STUDY_CHAIR

Lund University

Börje Haraldsson, Prof

Role: STUDY_CHAIR

Sahlgrenska University Hospital, Göteborg, Sweden

François Vrtovsnik, Prof

Role: STUDY_CHAIR

Bichat -Claude Bernard Hospital, Paris, France

Vedat Schwenger, Dr

Role: STUDY_CHAIR

Universitätsklinik University Hospital, Heidelberg, Germany

Locations

Rigshospitalet

Copenhagen, , Denmark

CHU Saint-Jacques

Besançon, , France

CHRU

Caen, , France

Hospital of Chambéry

Chambéry, , France

CH Colmar

Colmar, , France

Calydial Dialysis Center

Irigny, , France

Bichat-Claude Bernard Hospital

Paris, , France

ARPDD

Reims, , France

CHRU de Strasbourg

Strasbourg, , France

KfH-Nierenzentrum

Cologne, , Germany

KfH-Nierenzentrum am Krankenhaus Oststadt

Hanover, , Germany

University Hospital of Heidelberg

Heidelberg, , Germany

Nephrology center Offenburg

Offenburg, , Germany

KfH-Nierenzentrum

Passau, , Germany

PHV - Nephrologisches Zentrum Stuttgart

Stuttgart, , Germany

KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder

Trier, , Germany

Södra Älvborgsläns Hospital

Borås, , Sweden

University Hospital of Sahlgrenska

Gothenburg, , Sweden

University Hospital of Lund

Lund, , Sweden

University Hospital of Malmö

Malmo, , Sweden

Skarborgs Hospital

Skövde, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Norra Älvsborgs Hospital

Trollhättan, , Sweden

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Southmead Hospital

Bristol, , United Kingdom

The Royal London Hospital

London, , United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

University of North Staffordshire - Renal Medicine - Royal Infirmary

Stoke-on-Trent, , United Kingdom

Wolverhampton New Cross Hospital

Wolverhampton, , United Kingdom

Countries

Denmark; France; Germany; Sweden; United Kingdom

Other Identifiers

EudraCT 2007-005365-35

Identifier Type: -

Identifier Source: secondary_id

1449

Identifier Type: -

Identifier Source: org_study_id