Clinical trial NCT00965094: Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF)
timeFrame: 9 months
Secondary outcomes:
measure: Assessment of GFR by the Cockcroft-Gault Method (LOCF)
timeFrame: 9 months
measure: Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death.
timeFrame: 9 months
measure: Participants Who Had Occurrence of Treatment Failure.
timeFrame: 9 months
measure: Change in Renal Function (Creatinine Slope)
timeFrame: 3 months, 5 months, 7 months, 9 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bemelman FJ, de Maar EF, Press RR, van Kan HJ, ten Berge IJ, Homan van der Heide JJ, de Fijter HW. Minimization of maintenance immunosuppression early after renal transplantation: an interim analysis. Transplantation. 2009 Aug 15;88(3):421-8. doi: 10.1097/TP.0b013e3181af1df6.