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

NCT00403416 | Completed Phase 1

• 1 other identifier: CAEB071A2203
• Study Type: interventional
• Target: 215
• Locations: 8 countries
• Sites: 28

Brief Summary

This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

Conditions

Kidney Transplantation

Keywords

AEB071; Tacrolimus; Mycophenolic acid; Basiliximab; Rejection; Kidney function; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up

  at 6 months

Secondary Outcomes (5)

• Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)

  at 6 months

• Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up

  at 3 and 12 months

• Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.

  at Month 3, 6 and 12

• Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms

  from Month 3 to Month 6

• Safety and tolerability

  at 3, 6 and 12 months

Study Arms (3)

Mycophenolic Acid / tacrolimus

ACTIVE COMPARATOR

Drug: Mycophenolic Acid

AEB071 / tacrolimus arm 1

EXPERIMENTAL

Drug: AEB071

AEB071 / tacrolimus arm 2

EXPERIMENTAL

Drug: AEB071

Interventions

AEB071 DRUG

AEB071 / tacrolimus arm 1; AEB071 / tacrolimus arm 2

Mycophenolic Acid DRUG

Mycophenolic Acid / tacrolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients of any race 18 years or older
• Adult recipients of a kidney transplant from a deceased or from a living donor
• Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.

You may not qualify if:

• Need for medication prohibited by the protocol
• Patients or donors infected with hepatitis B or C, or with HIV.
• Patients with a history of cancer
• Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

University of California, San Francisco

San Francisco, California, 94143-0780, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106-5048, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-7375, United States

Location

QE II Health Sciences Center

Halifax, B3H 1V7, Canada

Location

Hopital Kremlin Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

Hopital Hotel Dieu

Nantes, 44035, France

Location

Hopital Necker

Paris, 75015, France

Location

CHU de Rangueil

Toulouse, 31403, France

Location

Universitaetsklinik Charite

Berlin, 10117, Germany

Location

Klinikum der Humboldt Universitat Charite

Berlin, 13353, Germany

Location

Staedt. Krankenhaus Koeln-Merheim

Cologne, 51109, Germany

Location

Universitaetsklinikum Essen

Essen, 45122, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Univ. - Klinikum Heidelberg

Heidelberg, 69120, Germany

Location

Az. Osp. Di Bologna Polici. S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Azienda Opedaliera Careggi - Universita degli Studi

Florence, 50134, Italy

Location

Azienda Ospedaliera di Padova - Universita degli Studi

Padua, 35128, Italy

Location

Ciutat Santitaria I Univessitaria de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Complejo Hospitalario Carlos Haya

Málaga, 28041, Spain

Location

Hospital Doctor Peset

Valencia, 46017, Spain

Location

Universitatsspital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Saint George's University of London

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Related Links

• Results for CAEB071A2203 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Rejection, Psychology

Interventions

sotrastaurin; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 23, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 17, 2020

Record last verified: 2017-05

Locations

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