A Phase 3 interventional study of Solution for Peritoneal Dialysis in Chronic Kidney Failure, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 29 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-27.
Sponsored by Fresenius Medical Care Deutschland GmbH · Phase 3, Interventional, and Treatment
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:
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's planned enrollment of 140 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
Drug: Solution for Peritoneal Dialysis
Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months
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.
Time frame: At the beginning and after 8 weeks of treatment
Measurement of Residual Renal Function
Time frame: At the beginning, at two and six months of treatment
Follow-up of frequency of hyponatremia, of AE and SAE
Time frame: During whole period of the study
Assessment of changes in sodium removal
Time frame: At the beginning and at two months of treatment
Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
Time frame: At the beginning, at two and at six months of treatment
Measurement of 24hours peritoneal clearance
Time frame: At the beginning and at 2 months of treatment
Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
Time frame: At the beginning, at two and six months of treatment
Office systolic and diastolic blood pressure measurement during follow up period
Time frame: End of treatment, follow-up period
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Fresenius Medical Care Deutschland GmbH