Chronic Kidney Failure Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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