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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Failure	Drug: Solution for Peritoneal Dialysis	Phase 3

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: PDsol 12; Treatment with a peritoneal dialysis solution containing a low concentration of sodium.	Drug: Solution for Peritoneal Dialysis; Treatment with one bag per day during 6 months
Active Comparator: Gambrosol trio 40; Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)	Drug: Solution for Peritoneal Dialysis; Treatment with one bag per day during 6 months

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Measurement of Residual Renal Function [ Time Frame: At the beginning, at two and six months of treatment ]
2. Follow-up of frequency of hyponatremia, of AE and SAE [ Time Frame: During whole period of the study ]
3. Assessment of changes in sodium removal [ Time Frame: At the beginning and at two months of treatment ]
4. 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 ]
5. Measurement of 24hours peritoneal clearance [ Time Frame: At the beginning and at 2 months of treatment ]
6. 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 ]
7. Office systolic and diastolic blood pressure measurement during follow up period [ Time Frame: End of treatment, follow-up period ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Denmark

Rigshospitalet

Copenhagen, Denmark

France

CHU Saint-Jacques

Besançon, France, 25000

CHRU

Caen, France, 14033

Hospital of Chambéry

Chambery, France

CH Colmar

Colmar, France

Calydial Dialysis Center

Irigny, France

Bichat-Claude Bernard Hospital

Paris, France

ARPDD

Reims, France, 51726

CHRU de Strasbourg

Strasbourg, France

Germany

KfH-Nierenzentrum am Krankenhaus Oststadt

Hannover, Germany, 30659

University Hospital of Heidelberg

Heidelberg, Germany

KfH-Nierenzentrum

Köln, Germany, 51109

Nephrology center Offenburg

Offenburg, Germany

KfH-Nierenzentrum

Passau, Germany, 94032

PHV - Nephrologisches Zentrum Stuttgart

Stuttgart, Germany

KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder

Trier, Germany, 54292

Sweden

Södra Älvborgsläns Hospital

Borås, Sweden

University Hospital of Sahlgrenska

Göteborg, Sweden

University Hospital of Lund

Lund, Sweden

University Hospital of Malmö

Malmö, Sweden

Skarborgs Hospital

Skövde, Sweden

Karolinska University Hospital

Stockholm, Sweden, 14186

Norra Älvsborgs Hospital

Trollhättan, Sweden

United Kingdom

Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

The Royal London Hospital

London, United Kingdom, E1 1BB

Royal Shrewsbury Hospital

Shrewsbury, United Kingdom, SY3 8XQ

University of North Staffordshire - Renal Medicine - Royal Infirmary

Stoke on Trent, United Kingdom, ST47LN

Wolverhampton New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Sponsors and Collaborators

Fresenius Medical Care Deutschland GmbH

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

More Information

• Responsible Party: Fresenius Medical Care Deutschland GmbH
• ClinicalTrials.gov Identifier: NCT00794326 History of Changes
• Other Study ID Numbers: 1449; EudraCT 2007-005365-35
• First Posted: November 20, 2008
• Last Update Posted: February 27, 2015
• Last Verified: September 2014

Keywords provided by Fresenius Medical Care Deutschland GmbH:

Chronic Kidney Failure; Peritoneal Dialysis; Low sodium solution; Hypertension; Total Body Water

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Dialysis Solutions; Pharmaceutical Solutions