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Neoral

Phase 3

Kidney Transplantation | Small molecule | Nephrology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment539

FDA Designations

No designations recorded

Clinical trial landscape

Neoral · 1 trial · 1 indication

Phase 3 1
NCT00048152A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant PatientsKidney Transplantation
COMPLETED539 Analytics
PHASE3COMPLETED
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Kidney Transplantation
NCT00048152539
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Study Endpoints

Primary Endpoints

Renal function (as measured by GFR)
12 months post-transplant

Secondary Endpoints

Patient and graft survival \n
12 months post-transplant
Proportion of patients with biopsy-proven rejection; treatment failure.
6 and 12 months post-transplant
AEs, OIs, malignancies, deaths
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
CorticosteroidsDRUGAs prescribed
NeoralDRUGLow dose (target trough level 50-100ng/mL)
ZenapaxDRUG2mg/kg iv first dose, then 1mg/kg every 2 weeks
mycophenolate mofetil [CellCept]DRUG1g po bid
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * adult patients greater than 18 years of age * recipients of primary kidney transplant * single-organ recipients (kidney only) Exclusion Criteria: * previous treatment with Zenapax * history of malignancy (except localized skin cancer)

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyMexicoNorwayPolandSpainSwedenUnited Kingdom
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