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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00794326Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PDPHASE3 COMPLETED 140 — — Oct 1, 2008Dec 1, 2014Feb 27, 201529 Denmark, France +3
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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 — 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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