Everolimus in Combination With Cyclosporine Microemulsion... | NCT00170885

Studies
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

NCT00170885

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 16, 2016Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Kidney Transplantation

Interventions

Everolimus

Countries

Switzerland

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

Status Module

Record Verification Date

Nov 2016

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

May 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 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

Nov 15, 2016

Last Update Posted Date

Nov 16, 2016Estimated

Description Module

Brief Summary

The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK)
Count of CD4 and CD8 positive lymphocytes
Metabolic control: lipids, glycaemic control, proteinuria, enzymes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
The renal cold ischemic time must be < 36 hours.
The age of the donor must be between 15 and 65 years.

Exclusion Criteria:

Patients who are recipients of multiple organ transplants, including more than one kidney
Patients who have previously received an organ transplant which failed within one year
Patients with current panel reactive T-cell antibody titers of 50% or more
Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

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

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Novartis	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21540717	Result	Ponticelli C, Salvadori M, Scolari MP, Citterio F, Rigotti P, Veneziano A, Bartezaghi M; EVEREST Study. Everolimus and minimization of cyclosporine in renal transplantation: 24-month follow-up of the EVEREST study. Transplantation. 2011 May 27;91(10):e72-3. doi: 10.1097/TP.0b013e318216c1db. No abstract available.

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals