Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 19, 2007

Last Updated Date

May 6, 2009

Start Date ^†

September 2006

Current Primary Outcome Measures ^†

Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00464399 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio

Original Secondary Outcome Measures ^†

Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio

Descriptive Information

Brief Title ^†

Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients

Official Title ^†

A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant

Brief Summary

To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

De Novo Renal Transplantation

Intervention ^†

Drug: everolimus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Male or female aged above 18 years.
Patients having received their first or second single renal transplant from deceased or living donor
Patient willing and capable of giving written informed consent for study participation
Patients treated with as induction therapy at the time of transplantation
Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant
Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.

Exclusion Criteria:

Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
Patients with antibodies towards the donor kidney above 30%
Patients receiving a renal transplant from HLA-identical sibling
Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
Patients who are recipients of AB0 incompatible transplants
Patients with unsuitable laboratory values
Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
Patient with a current severe major local or systemic infection
Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) < 20 ml/min
Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch
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

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Norway

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00464399

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.