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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT00794326
First received: November 18, 2008
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Chronic Kidney Failure
Drug: Solution for Peritoneal Dialysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of Residual Renal Function [ Time Frame: At the beginning, at two and six months of treatment ] [ Designated as safety issue: No ]
  • Follow-up of frequency of hyponatremia, of AE and SAE [ Time Frame: During whole period of the study ] [ Designated as safety issue: Yes ]
  • Assessment of changes in sodium removal [ Time Frame: At the beginning and at two months of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measurement of 24hours peritoneal clearance [ Time Frame: At the beginning and at 2 months of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Office systolic and diastolic blood pressure measurement during follow up period [ Time Frame: End of treatment, follow-up period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794326

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

No publications provided

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00794326     History of Changes
Other Study ID Numbers: 1449, EudraCT 2007-005365-35
Study First Received: November 18, 2008
Last Updated: September 23, 2014
Health Authority: Sweden: Medical Products Agency
France: ANSM - French Health Products Safety Agency
France: Institutional Ethical Committee
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Germany: Ethics Commission
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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
Pharmaceutical Solutions
Dialysis Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014