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

De Novo Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464399
• Other study ID #: CRAD001ANO01
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2007
• Last updated: November 15, 2016
• Start date: September 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Statens Legemiddelverk (SLV)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2012
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• De Novo Renal Transplantation

Intervention

Drug:
• everolimus

Locations

Country	Name	City	State
Norway	Novartis Investigative Site,	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Holdaas H, Bentdal O, Pfeffer P, Mjørnstedt 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.1399-00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
Secondary	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