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

NCT00794326 | Completed Phase 3 DMC

• 2 other identifiers: 1449EudraCT 2007-005365-35
• Study Type: interventional
• Target: 140
• Locations: 5 countries
• Sites: 29

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.

Conditions

Chronic Kidney Failure

Keywords

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

Outcome Measures

Primary Outcomes (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.

  At the beginning and after 8 weeks of treatment

Secondary Outcomes (7)

• Measurement of Residual Renal Function

  At the beginning, at two and six months of treatment

• Follow-up of frequency of hyponatremia, of AE and SAE

  During whole period of the study

• Assessment of changes in sodium removal

  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

  At the beginning, at two and at six months of treatment

• Measurement of 24hours peritoneal clearance

  At the beginning and at 2 months of treatment

Study Arms (2)

PDsol 12

EXPERIMENTAL

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

Drug: Solution for Peritoneal Dialysis

Gambrosol trio 40

ACTIVE COMPARATOR

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

Drug: Solution for Peritoneal Dialysis

Interventions

Solution for Peritoneal Dialysis DRUG

Treatment with one bag per day during 6 months

Gambrosol trio 40; PDsol 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (29)

Rigshospitalet

Copenhagen, Denmark

Location

CHU Saint-Jacques

Besançon, 25000, France

Location

CHRU

Caen, 14033, France

Location

Hospital of Chambéry

Chambéry, France

Location

CH Colmar

Colmar, France

Location

Calydial Dialysis Center

Irigny, France

Location

Bichat-Claude Bernard Hospital

Paris, France

Location

ARPDD

Reims, 51726, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

KfH-Nierenzentrum

Cologne, 51109, Germany

Location

KfH-Nierenzentrum am Krankenhaus Oststadt

Hanover, 30659, Germany

Location

University Hospital of Heidelberg

Heidelberg, Germany

Location

Nephrology center Offenburg

Offenburg, Germany

Location

KfH-Nierenzentrum

Passau, 94032, Germany

Location

PHV - Nephrologisches Zentrum Stuttgart

Stuttgart, Germany

Location

KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Södra Älvborgsläns Hospital

Borås, Sweden

Location

University Hospital of Sahlgrenska

Gothenburg, Sweden

Location

University Hospital of Lund

Lund, Sweden

Location

University Hospital of Malmö

Malmo, Sweden

Location

Skarborgs Hospital

Skövde, Sweden

Location

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Norra Älvsborgs Hospital

Trollhättan, Sweden

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, SY3 8XQ, United Kingdom

Location

University of North Staffordshire - Renal Medicine - Royal Infirmary

Stoke-on-Trent, ST47LN, United Kingdom

Location

Wolverhampton New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Interventions

Dialysis Solutions

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 20, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 27, 2015

Record last verified: 2014-09

Locations

DK (1); GB (6); SE (7); FR (8); DE (7)