Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00965094
First received: August 24, 2009
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant patients.


Condition Intervention Phase
Chronic Renal Failure
Drug: Everolimus
Drug: Prograf
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Certican® (Everolimus) in Combination With Myfortic® (EC-MPS, Enteric-coated Mycophenolate Sodium) After Early CNI Elimination Versus Myfortic® in Combination With Prograf® in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function assessed as glomerula filtration rate (GFR) - Nankivell method - 9 months after renal transplantation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal function by GFR [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • biopsy proven acute rejection, graft loss, death occurrence of treatment failures, while treatment failure is defined as a composite endpoint [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • evolution of renal function (creatinine slope) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • to assess safety and tolerability between Month 3 and 9 (according to safety parameters specified in chapter 7.5 of this protocol) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2009
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Everolimus
Drug: Everolimus
Everolimus
Active Comparator: 2
Prograf
Drug: Prograf
Prograf

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Recipients of de novo cadaveric, living unrelated or living related kidney transplants
  • Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
  • Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria:

  • More than one previous renal transplantation
  • Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
  • Donor age: < 5 years or > 65 years
  • Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
  • Patients who had received an investigational drug within 4 weeks of the baseline period
  • Patients who are recipients of A-B-O incompatible transplants or T cell cross-match positive transplants
  • Patients with already existing antibodies against the HLA-type of the receiving transplant
  • Patients with any known hypersensitivity to Simulect®, Certican®, mycophenolic acid, Prograf®, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations.
  • Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
  • Patients with thrombocytopenia (platelets < 75,000/mm³), or an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dL
  • Patients with preexisting lung disease (alveolitis, fibrosis) Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
  • Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
  • Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
  • Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
  • Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating, and/or who are unwilling to use effective means of contraception (see also section 8.2)
  • Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
  • Evidence of drug or alcohol abuse
  • Patients receiving drugs known to interact with Tacrolimus and/or everolimus according to the list provided in Appendix 3 to this protocol.
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965094

Locations
Israel
Novartis Investigative Site
Haifa, Israel, 31096
Novartis Investigative Site
Tel Aviv, Israel, 64239
Novartis Investigative Site
Tiqwa, Israel, 49100
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00965094     History of Changes
Other Study ID Numbers: CRAD001AIL03
Study First Received: August 24, 2009
Last Updated: March 5, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014