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

Chronic Kidney Failure Clinical Trial

— PDOne  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794326
• Other study ID #: 1449
• Secondary ID: EudraCT 2007-005
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2008
• Last updated: February 26, 2015
• Start date: October 2008
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFrance: ANSM - French Health Products Safety AgencyFrance: Institutional Ethical CommitteeGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeGermany: Ethics CommissionUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
France	CHU Saint-Jacques	Besançon
France	CHRU	Caen
France	Hospital of Chambéry	Chambery
France	CH Colmar	Colmar
France	Calydial Dialysis Center	Irigny
France	Bichat-Claude Bernard Hospital	Paris
France	ARPDD	Reims
France	CHRU de Strasbourg	Strasbourg
Germany	KfH-Nierenzentrum am Krankenhaus Oststadt	Hannover
Germany	University Hospital of Heidelberg	Heidelberg
Germany	KfH-Nierenzentrum	Köln
Germany	Nephrology center Offenburg	Offenburg
Germany	KfH-Nierenzentrum	Passau
Germany	PHV - Nephrologisches Zentrum Stuttgart	Stuttgart
Germany	KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder	Trier
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	Norra Älvsborgs Hospital	Trollhättan
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measurement of Residual Renal Function		At the beginning, at two and six months of treatment	No
Secondary	Follow-up of frequency of hyponatremia, of AE and SAE		During whole period of the study	Yes
Secondary	Assessment of changes in sodium removal		At the beginning and at two months of treatment	No
Secondary	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	No
Secondary	Measurement of 24hours peritoneal clearance		At the beginning and at 2 months of treatment	No
Secondary	Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0		At the beginning, at two and six months of treatment	No
Secondary	Office systolic and diastolic blood pressure measurement during follow up period		End of treatment, follow-up period	Yes