Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

Kidney Transplantation Clinical Trial

Official title:

Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514514
• Other study ID #: CRAD001ADE13
• Secondary ID: 2006-007021-32
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2007
• Last updated: March 23, 2016
• Start date: July 2007
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria

• Males or females, aged 18 - 70 years

• Recipients of de novo cadaveric, living unrelated or living related kidney transplants

• Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.

• Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

• More than one previous renal transplantation

• Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney

• Patients receiving a kidney from a non-heart beating donor

• Donor age: < 5 years or > 70 years

• Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Everolimus
experimental
• Myfortic and Neoral
active comparator

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover Muenden
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Kaiserslautern
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Regensburg
Switzerland	Novartis Investigative Site	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function assessed by glomerular filtration rate (GFR) - Nankivell method - 12 months after renal transplantation (Tx)	The primary objective of this trial is to demonstrate superiority of a CNI-free regimen respect to the renal function at Month 12 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard regimen in de novo kidney transplant patients.	48 Mth	Yes
Secondary	Renal function glomerular filtration rate M12 post by serum creat.at M12 post Tx Efficacy(biopsy proven acute ejection,graft loss,death) at M6&M12 Occurrence treatment failures up to or at M12, Evolution of renal function between M3&M12 creatinine slope		48 Mth	Yes