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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014