Freedom Study: Myfortic in Kidney Transplant Patients

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00101738

Collaborator

(none)

342

Enrollment

Locations

Duration (Months)

7.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Myfortic	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

342 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

Calculated glomerular filtration rate after 12 months treatment []

Secondary Outcome Measures

Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months. []
Patient and graft survival after 12 months. []
Incidence of AEs and SAEs after 3 and 12 months. []
Blood pressure, lipids and glucose profiles after 3 and 12 months. []
Percentage of patients free of steroids at 12 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females aged 18 to 75 years.
Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.

Exclusion Criteria:

Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
Kidneys from non-heart beating donors or HLA identical living related donors.
ABO incompatibility against the donor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Kidney Transplant Service	San Francisco	California	United States	94143-0780
2	Livelink, Inc.	Tampa	Florida	United States	33606
3	Loyola Medical Center	Maywood	Illinois	United States	60153
4	Indiana U. Medical Center	Indianapolis	Indiana	United States	46202
5	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
6	University Hospitals of Cleveland, Division of Nephrology	Cleveland	Ohio	United States	44106
7	Ohio State University Medical Center	Columbus	Ohio	United States	43210
8	Legacy Research & Technology Ctr.	Portland	Oregon	United States	97232
9	U. of Wisconsin Hospital Clinics	Madison	Wisconsin	United States	53792-7375
10	Crai Norte	San Martin	Buenos Aires	Argentina	1650
11	Hospital Cordoba	Cordoba		Argentina	5000
12	Unidad de Transplante Velez Sarsfield	Cordoba		Argentina	X5016JDA
13	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
14	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
15	The Queen Elizabeth Hospital	Woodville	South Australia	Australia	5011
16	Monash Medical Centre	Clayton	Victoria	Australia	3168
17	Royal Melbourne Hospital	Parkville	Victoria	Australia	3052
18	Hospital das Clinicas - UNICAMP	Campinas	SP	Brazil	13083-970
19	Hipertensao Hospital do Rim e Hipertensao	Sao Paulo	SP	Brazil	04023 900
20	Foothills Medical Center	Calgary	Alberta	Canada	T2N 2T9
21	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2B7
22	Queen II Health and Science Center	Halifax	Nova Scotia	Canada	B3H 2Y6
23	St. Michael's Hospital	Toronto	Ontario	Canada	M5C 2T2
24	University Health Network, The Toronto Hospital	Toronto	Ontario	Canada	M5G 2C4
25	McGill University Health Centre	Montreal	Quebec	Canada	H3A 1A1
26	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W8
27	Klinikum der Johann Wolfgang Geothe-Universitaet	Frankfurt am Main		Germany	60596
28	Staedt. Krankenhaus Koeln-Merheim	Koeln		Germany	51109
29	Ospedale Consorziale e policlinico-Universita degli Studi	Bari	BA	Italy	70124
30	Hospital Kuala Lumpur	Kuala Lumpur		Malaysia	50586
31	Auckland Hospital	Auckland	Grafton	New Zealand
32	Singapore General Hospital	Singapore		Singapore	169608
33	Hospital de Bellvitge	L'hospitalet de Llobregat		Spain	08907
34	Hospital Clinico San Carlos	Madrid		Spain	28040
35	Hospital Central de Asturias	Oviedo		Spain	33006
36	Chang-Gung Memorial Hospital-Linko	Tao-Yuan	Lin-Ko	Taiwan	333
37	Taipei Veterans General Hospital	Taipei	ROC	Taiwan
38	National Taiwan University Hospital	Taipei		Taiwan	100
39	Queen Elizabeth Medical Centre	Edgbaston	Birmingham	United Kingdom	B15 2TH
40	University Hospital of Wales	Heath Park	Cardiff	United Kingdom	CF14 4XW
41	Walsgrave Hospital NHS Trust	Walsgrave	Coventry	United Kingdom	CV2 2DX
42	Freeman Hospital	High Heaton	Newcastle Upon Tyne	United Kingdom	NE7 7DN
43	Guy's Hospital	London		United Kingdom	SE1 9RT
44	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1BP