NCT00555789

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
8 countries

27 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

December 17, 2020

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

November 8, 2007

Last Update Submit

December 11, 2020

Conditions

Kidney Transplantation

Keywords

kidney transplantationrejectionAEB071tacrolimusmycophenolic acidimmunosuppression

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

mycophenolic and tacrolimus

Drug: mycophenolic plus tacrolimus

2

EXPERIMENTAL

mycophenolic and tacrolimus

Drug: AEB071

Interventions

AEB071DRUG

200mg oral b.i.d.

Also known as: mycophenolic plus tacrolimus
2
mycophenolic plus tacrolimusDRUG

720mg b.i.d. 2yrs

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Novartis Investigative Site

San Francisco, California, 94143-0780, United States

Location

Novartis Investigative Site

Madison, Wisconsin, 53706, United States

Location

Novartis Investigative Site

Halifax, B3H 1V7, Canada

Location

Novartis Investigative Site

Le Kremlin-Bicêtre, 94270, France

Location

Novartis Investigative Site

Nantes, 44035, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Toulouse, 31403, France

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Cologne, Germany

Location

Novartis Investigative Site

Essen, 45122, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Bologna, 40138, Italy

Location

Novartis Investigative Site

Florence, 50134, Italy

Location

Novartis Investigative Site

Padua, 35128, Italy

Location

Novartis Investigative Site

Llobregat, 08907, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Málaga, 28041, Spain

Location

Novartis Investigative Site

Valencia, 46017, Spain

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

Location

Novartis Investigative Site

Glasgow, G11 6NT, United Kingdom

Location

Novartis Investigative Site

London, United Kingdom

Location

Novartis Investigative Site

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Rejection, Psychology

Interventions

sotrastaurinTacrolimus

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

December 17, 2020

Record last verified: 2012-07

Locations

GB(4)US(2)DE(6)CA(1)IT(3)ES(4)CH(3)FR(4)