24 Month Extension to Efficacy and Safety of AEB071 Plus... | NCT00555789

Studies
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

NCT00555789

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Dec 17, 2020Actual

Enrollment

137Actual

Phase

Phase 2

Conditions

Kidney Transplantation

Interventions

AEB071
mycophenolic plus tacrolimus

Countries

United States
Canada
France
Germany
Italy
Spain
Switzerland
United Kingdom

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

Official Title

A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Nov 8, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

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

Jul 9, 2012

Certification/Extension First Submitted that Passed QC Review

Jul 31, 2012

Certification/Extension First Posted Date

Aug 7, 2012Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Description Module

Brief Summary

This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	mycophenolic and tacrolimus	Drug: mycophenolic plus tacrolimus
2	Experimental	mycophenolic and tacrolimus	Drug: AEB071

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AEB071	Drug	200mg oral b.i.d.	2	mycophenolic plus tacrolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months.		three Yrs

Secondary Outcomes

Measure	Description	Time Frame
Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms.		Three yrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Participation in core study CAEB071A2203
The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).

Exclusion criteria:

Pregnancy. 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	Novartis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		San Francisco	California	94143-0780	United States
Novartis Investigative Site

References Module

Citations

Not provided

ID	Term
D012919	Social Behavior
D001519	Behavior

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals