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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00464399

Purpose

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.

Condition	Intervention	Phase
De Novo Renal Transplantation	Drug: everolimus	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant

Further study details as provided by Novartis:

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

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

Estimated Enrollment:	20
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464399

Locations

Norway
Novartis Investigative Site,
Oslo, Norway

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	CRAD001ANO01
Study First Received:	April 19, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00464399
Health Authority:	Norway: Statens Legemiddelverk (SLV)

Keywords provided by Novartis:

De novo renal transplantation
CNI-free protocol
adults
everolimus
rejections

Study placed in the following topic categories:

Everolimus
Cyclosporine
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009