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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00464399
First received: April 19, 2007
Last updated: March 6, 2014
Last verified: March 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant

Resource links provided by NLM:


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
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  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 Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00464399     History of Changes
Other Study ID Numbers: CRAD001ANO01
Study First Received: April 19, 2007
Last Updated: March 6, 2014
Health Authority: Norway: Statens Legemiddelverk (SLV)

Keywords provided by Novartis:
De novo renal transplantation
CNI-free protocol
adults
everolimus
rejections

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Everolimus
Sirolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 14, 2014