Investigate if a peritoneal dialysis solution with less sodium can improve blood pressure and overhydration when treated on peritoneal dialysis.

• Conditions: Patients with chronic renal disease treated on peritoneal dialysis and diagnosed for hypertension.; MedDRA version: 14.1Level: PTClassification code 10034660Term: Peritoneal dialysisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10067974Term: Automated peritoneal dialysisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10064116Term: Continuous ambulatory peritoneal dialysisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2007-005365-35-GB
• Lead Sponsor: Fresenius Medcial Care Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

- Chronic renal failure - Stable on PD treatment - Treated in a CAPD(Continous Ambulatory peritoneal Dialysis) or in an APD program using with a daytime bag-exchange duration of 4-6 hours using one low strength glucose bag - Hypertensive patients (Office blood pressure SBP = 140 and/or DBP = 90 mmHg) or hypertensive patients receiving antihypertensive medication including diuretics, disregarding blood pressure values (Patients in the range 120 - 140 mmHg SBP can be included if they are diagnosed for hypertension. The final decision for being eligeable is the mean 24h = 105 mmHg SBP. - Signed informed consent - Life expectancy and expected technical survival = 9 months
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Low blood pressure (Office sitting SBP = 120 mmHg and confirmed by ABPM = 105 mmHg mean 24 SBP) - Orthostatic hypotension defined as Systolic OBP with a drop of >20 mmHg and symptomatic after standing for at least 1 minute - Natraemia < 130 mmol/l, after two consecutive measurements - Chronic arhythmia - Peritonitis within one month prior to the study start

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified