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for Peritoneal Dialysis

Phase 3

Chronic Kidney Failure | Small molecule | Nephrology |Fresenius Medical Care AG|Trials Updated: Feb 27, 2015

for Peritoneal Dialysis target and mechanism

ModalitySmall molecule

Also known as Solution for Peritoneal Dialysis

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

for Peritoneal Dialysis clinical trials

for Peritoneal Dialysis · 1 trial · 1 indication

Phase 3 1
NCT00794326Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PDChronic Kidney Failure
COMPLETED140 Analytics
PHASE3COMPLETED
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
Chronic Kidney FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Measurement of Residual Renal Function
At the beginning, at two and six months of treatment
Follow-up of frequency of hyponatremia, of AE and SAE
During whole period of the study
Assessment of changes in sodium removal
At the beginning and at two months of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PDsol 12EXPERIMENTALTreatment with a peritoneal dialysis solution containing a low concentration of sodium.
Gambrosol trio 40ACTIVE_COMPARATORTreatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)

Interventions

NameTypeDescription
Solution for Peritoneal DialysisDRUGTreatment with one bag per day during 6 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

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 stren...

Countries:DenmarkFranceGermanySwedenUnited Kingdom
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Frequently asked questions about for Peritoneal Dialysis

What is Solution for Peritoneal Dialysis?

Solution for Peritoneal Dialysis is an investigational small molecule therapy being developed by Fresenius Medical Care AG for chronic kidney failure. It is a low sodium peritoneal dialysis solution designed for patients with chronic kidney failure who are treated with peritoneal dialysis. It is also known as Solution for Peritoneal Dialysis.

What is Solution for Peritoneal Dialysis used for?

Solution for Peritoneal Dialysis is being studied for use in patients with chronic kidney failure who are treated with peritoneal dialysis. The development program focuses on hypertensive patients receiving peritoneal dialysis, evaluating a low sodium peritoneal dialysis solution in that population.

Who makes Solution for Peritoneal Dialysis?

Solution for Peritoneal Dialysis is developed by Fresenius Medical Care AG, which trades under the ticker FMS. Fresenius Medical Care AG is the sponsor of the clinical program evaluating this low sodium peritoneal dialysis solution in patients with chronic kidney failure.

What phase is Solution for Peritoneal Dialysis in?

Solution for Peritoneal Dialysis is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program has completed one trial, and no trials are currently active.

What clinical trials is Solution for Peritoneal Dialysis in?

Solution for Peritoneal Dialysis has been evaluated in one completed Phase 3 trial, NCT00794326, titled Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD. The trial enrolled 140 patients with chronic kidney failure across Denmark, France, Germany, Sweden, and the United Kingdom.