Chronic Kidney Failure Clinical Trial
— PDOneOfficial 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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Fresenius Medical Care Deutschland GmbH |
Denmark, France, Germany, Sweden, United Kingdom,
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 |
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