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Electronic Decision Support

Phase 3

Chronic Kidney Disease | Unknown | Nephrology |Harvard Bioscience, Inc.|Last Updated: Feb 15, 2013

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
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01203813A Risk Based Approach to Improving Chronic Kidney Disease ManagementPHASE3 COMPLETED 10,000May 1, 2011Jan 1, 2013Feb 15, 20131 United States
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Study Endpoints
Primary Endpoints
Annual Nephrology Evaluation
At 18 months

Patients with high risk chronic kidney disease (eGFR 30 to 45; or eGFR 45 to 60 with concurrent diabetes or proteinuria) should receive a nephrology office evaluation within the prior 12 months

Appropriate ACE/ARB Use
At 18 months

Patients with chronic kidney disease (eGFR 30 to 60) with concurrent diabetes, proteinuria, or hypertension should receive a prescription for ACE/ARB within the prior 12 months

Annual lab monitoring for CKD
At 18 months

Patients with chronic kidney disease (eGFR 30 to 60) should have the following labs checked within the prior 12 months: 1. eGFR/ creatinine 2. Lipid profile 3. Calcium 4. Vitamin D 5. Parathyroid hormone 6. Phosphorous 7. Hemoglobin 8. Urine microalbumin

Secondary Endpoints
Outcomes According to Primary Care Use
At 18 months
Outcomes According to Physician Attitudes
At 18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
Physician InterventionEXPERIMENTALPhysicians randomized to the intervention will receive: 1. Electronic alerts during office visits for patients with chronic kidney disease 2. Opportunity to enroll their patients with chronic kidney disease in a self management support outreach program
Physician ControlNO_INTERVENTIONPhysicians randomized to the control arm will continue to manage their patients with chronic kidney disease according to routine primary care standards.
Interventions
NameTypeDescription
Electronic Decision SupportOTHERPhysicians randomized to the intervention will receive: 1. Electronic alerts during office visits for patients with chronic kidney disease 2. Opportunity to enroll their patients with chronic kidney disease in a self management support outreach program
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Stage 3 chronic kidney disease based on at least 2 eGFR 30-60 (separated by 90 days) within the prior 5 years * Must be at least 18 years of age * Must have a primary care visit at one of 15 of the HVMA health centers within the last 18 months Exclusion Criteria: * Age \> 85...

Countries:United States
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