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Zemplar

Phase 3

Kidney Disease | Small molecule | Nephrology |Abbott Laboratories|Last Updated: Jan 19, 2011

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00091975Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal DialysisPHASE3 COMPLETED 78Aug 1, 2004 -Jan 19, 201116 United States
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Study Endpoints
Primary Endpoints
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Zemplar CapsuleDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria * Subject was at least 18 years of age, diagnosed with CKD Stage 5 and undergoing HD or PD. * If female, subject was either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hys...

Countries:United States
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