Subjects with renal failure treated with peritoneal dialysis MedDRA version: 17.0 Level: LLT Classification code 10009119 Term: Chronic renal failure System Organ Class: 100000004857
Conditions
Interventions
Product Name: PDsol 12
Product Code: PDsol 12
Pharmaceutical Form: Solution for peritoneal dialysis
INN or Proposed INN: Glucose
CAS Number: 50-99-7
Concentration unit: mmol/l millimole(s)/litre
Conce
Sponsors
Fresenius Medical Care Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Low blood pressure (Office sitting SBP =120 mmHg and confirmed by ABPM =105 mmHg mean SBP) - Ortostatic hypotension defined as systolic OBP with a drop of >20 mmHg and symptomatic after 1 minute in standing position - Natremia <130 mmol/l, after two consecutive measurements - 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) - Patients with chronic arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess superiority of the new isotonic low sodium solution in comparison with standard isotonic glucose solution.;Secondary Objective: - To assess safety of low sodium dialysis treatment during a 6 month period (natremia, OBP and urine volume) - To assess changes in sodium removal at 2 months - To assess decrease in total body water (TBW) at 2 months (extra and intra cellular water) Exploratory exams to document the treatment: - Residual renal function - 24h clearance - TBW at 6 months In addition: - ABPM results will be analyzed closely to understand the effect of BP treatment behaviour;Primary end point(s): To increase the respons rate by 25% between patients with conventional isotonic solution Gambrosol trio and PDsol 12. • Improvement of arterial hypertension by a decrease of =6 mmHg on the mean 24h SBP, measured from ABPM (T2-Baseline) in patients without antihypertensive medication modification or • Documented occurrence of hypotension requiring a medical action as a decrease of antihypertensive drug medication, confirmed by the DSMB;Timepoint(s) of evaluation of this end point: At 2 months in comparison to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 2, 6 or 8 months after baseline according to parameter;Secondary end point(s): - Safety of the study product (No serious study product related safety issues, Frequency of hyponatremia and other adverse events, Residual Renal Function - Effect on blood pressure by a detailed analysis of ABPM recording and office blood pressure measurement (Mean 24h ABPM (diastolic) at 2 months compared to Baseline; Office systolic and diastolic blood pressure at month 2 and 6 versus T0; Office systolic and diastolic blood pressure during the 2 months study follow-up period to document the reversibility of product effect - Effect on over hydration through Sodium Removal during 1 dwell at 2 months compared to T0, Estimation of Sodium Removal during 24h at 2 months compared to T0, Estimations of changes in total body water and repartition (intra/extra cellular) on the 6 month study, Body weight changes | — |
Countries
Denmark, France, Germany, Sweden, United Kingdom
Contacts
Public ContactDepartment Clinical Research
Fresenius Medical Care Deutschland GmbH
Outcome results
None listed