Immediate Conversion From Tacrolimus to Everolimus in Sta... | NCT01269684

Studies
Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

NCT01269684

Sponsor

Novartis Pharmaceuticals

Status

Withdrawn

Last Update Posted

Feb 24, 2017Actual

Enrollment

0Actual

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patient has never been included in the trial

Expanded Access Info

Start Date

Aug 2008Actual

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Oct 5, 2010

First Submission Date that Met QC Criteria

Jan 3, 2011

First Posted Date

Jan 4, 2011Estimated

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

Feb 23, 2017

Last Update Posted Date

Feb 24, 2017Actual

Description Module

Brief Summary

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.

Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml	Drug: Everolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Routine safety laboratory		At baseline
Routine safety laboratory		Week 1
Routine safety laboratory		Month 1
Routine safety laboratory		Week 2
Routine safety laboratory		Week 3
Routine safety laboratory		Month 2
Routine safety laboratory		Month 4
Routine safety laboratory		Month 6

Secondary Outcomes

Measure	Description	Time Frame
renal function		At baseline
renal function		Weeks 1, 2 and 3
renal function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Primary or secondary renal transplantation in the past 12-36 months.
Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
Moderately impaired renal function

Exclusion criteria

Multi-organ recipients or previous transplantation with an organ other than a kidney.
Acute rejection episodes in the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Zurich			Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D000068338	Everolimus

Ancestor Terms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided