Clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertensio

Phase 1

• Conditions: Subjects with renal failure treated with peritoneal dialysis; MedDRA version: 17.0Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2007-005365-35-DE
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-06
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

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

Inclusion Criteria

- Chronic renal failure
- Stable patients on CAPD with a minimum of 3 bag exchanges including at least one 4-6 hour dwell or patients on APD with at least one daytime exchange lasting for at least 4-6 hours
- Hypertensive patients with high blood pressure at inclusion (Office SBP =140 mmHg and/or DBP =90 mmHg) or hypertensive patients receiving antihypertensive medication, including diuretics, disregarding blood pressure values.
- Patients aged 18 years or more
- written informed consent
- able to use 3-compartment bag
- life expectancy and expected technical survival of at least 9 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Low blood pressure (Office sitting SBP =120 mmHg and confirmed by ABPM =105 mmHg mean SBP)
- Orthostatic hypotension (defined as a fall in systolic OBP of at least 20 mmHg and symptomatic after standing for at least 1 minute)
- Natremia <130 mmol/l, after two consecutive measurments
- Peritonits within one month prior to study start
- Exite site and/or tunnel infection
- (Patients unable to tolerate 2 L bag exchanges - cancelled according to amendment 1, dated 04.06.2012 on version 6.0, dated 17.02.2011)
- Chronic arrhythmia

Study & Design

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