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

NCT00464399 | Completed Phase 3

• 1 other identifier: CRAD001ANO01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

De Novo Renal Transplantation

Keywords

De novo renal transplantation; CNI-free protocol; adults; everolimus; rejections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

everolimus DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site,

Oslo, Norway

Location

Related Publications (1)

• Holdaas H, Bentdal O, Pfeffer P, Mjornstedt L, Solbu D, Midtvedt K. Early, abrupt conversion of de novo renal transplant patients from cyclosporine to everolimus: results of a pilot study. Clin Transplant. 2008 May-Jun;22(3):366-71. doi: 10.1111/j.1399-0012.2008.00795.x. Epub 2008 Feb 12.

  PMID: 18279419 RESULT

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Study Start: September 1, 2006
• Primary Completion: December 1, 2012
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

NO (1)