Efficacy and Safety of FTY720 in de Novo Adult Renal Tran... | NCT00239785

Studies
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

NCT00239785

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Aug 22, 2017Actual

Enrollment

684

Phase

Phase 3

Conditions

Renal Transplantation

Interventions

FTY720

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Apr 2005Actual

Completion Date

Not provided

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 17, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2017

Last Update Posted Date

Aug 22, 2017Actual

Description Module

Brief Summary

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

684

Name	Type	Description	Arm Group Labels	Other Names
FTY720	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
Permanent resumption of dialysis within 12 months post transplant
Surgical removal of graft within 12 months post transplant
Death within 12 months post transplant
Withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary Outcomes

Measure	Description	Time Frame
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
Serum creatinine
Cystatin C at months 3, 6, and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male and female patients of any race between 18 to 65 years old (inclusive)
Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
Patients who gave written informed consent to participate in the study Exclusion Criteria
Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
Graft cold ischemia time greater than 40 hours.
Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Novartis	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D000068876	Fingolimod Hydrochloride

Ancestor Terms

ID	Term
D013110	Sphingosine
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

Not provided