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for Peritoneal Dialysis

Phase 3

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

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

Clinical trial landscape

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 Failure
NCT00794326140
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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 for Peritoneal Dialysis used for in Chronic Kidney Failure?

For Peritoneal Dialysis is a small molecule solution used in patients with Chronic Kidney Failure who are undergoing peritoneal dialysis. It is designed to manage hypertension in these patients, as evaluated in a Phase 3 clinical trial. The treatment is administered as part of the dialysis process.

Who makes for Peritoneal Dialysis?

For Peritoneal Dialysis is developed by Fresenius Medical Care AG, a company publicly traded under the ticker FMS. The company is conducting clinical research on this product for use in patients with Chronic Kidney Failure undergoing peritoneal dialysis.

What phase is for Peritoneal Dialysis in?

For Peritoneal Dialysis is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the product remains under evaluation for its intended use in Chronic Kidney Failure patients.

What clinical trials is for Peritoneal Dialysis in?

For Peritoneal Dialysis has one completed Phase 3 clinical trial registered as NCT00794326. The trial, titled 'Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD,' enrolled 140 participants with Chronic Kidney Failure across Denmark, France, Germany, Sweden, and the United Kingdom.

Is for Peritoneal Dialysis FDA approved?

For Peritoneal Dialysis is not FDA approved. It is an investigational product currently in Phase 3 clinical development. A completed Phase 3 trial has evaluated its use in Chronic Kidney Failure patients with hypertension, but regulatory approval has not been granted.