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Renal Allograft Recipients Study



Renal Allograft Recipients Study

For Condition: Renal Allograft Recipients
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: To determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Age greater than or equal to 13 years. - Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter. - Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization. - Six (6) to 60 months after renal transplantation. - All female patients at risk for pregnancy must have a negative serum pregnancy test before randomization. Female patients at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication. - Signed and dated informed consent before screening and before any tests are performed that are specific to the protocol. A parent or legal guardian must provide written consent for patients younger than the age of majority defined by state and local laws. Patients younger than the age of majority will also sign an assent form. Exclusion Criteria: - Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment. - Patients in whom kidney-pancreas or other multiple organ transplants have been performed
Total Enrollment: 

Location and Contact Information:

Westmeade Center c/o Delaware Valley Research Associates, Inc. *Recruiting*
Conshohocken,  Pennsylvania,  19428
United States
Recruiting Arthur  Matas 215-992-9620

Univ. of Texas School of Medicine - Dept.  of    Immunology  and  Organ  Transplantation *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Charles  Buren 713-500-7405

Nefrologisk afdelning P 2132 - Rigshospitalet *Recruiting*
Copenhagen,  ,  DK-2100
Denmark
Recruiting Soren  -Sorensen +45-35 452700

Servicio de Nefrologia - Hospital Universitario de Canarias *Recruiting*
La Laguna,  ,  38320
Spain
Recruiting J  Gonzalez -Posada 922 678 544

Clinica Chirurgica Generale IV - Universita degli Studi di Padova *Recruiting*
Padova,  ,  35100
Italy
Recruiting Ermanno  Ancona +39-049 8213151

Service de Transplantation Renale et de Chirurgie des Glandes Endocrines *Recruiting*
BRUXELLES,  ,  B-1200
Belgium
Recruiting Professor  Squifflet +32.2.764.11.11

Lifelink of Florida *Recruiting*
Tampa,  Florida,  33606
United States
Recruiting Samuel  Weinstein 813-253-2640

Westmead Hospital *Recruiting*
Westmead,  ,  2145
Australia
Recruiting Phillip  O'Connell 61298456259

Medical University of Warsaw - Department of Immunotherapy and Internal Diseases *Recruiting*
Warszawa,  ,  02-006
Poland
Recruiting Leszek  Paczek 48226285363

Medical College of Wisconsin - Froedbert Luthern Hospital *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Barbara  Bresnahan 414-456-6715

Ospedale Maggiore di Milano - Divisione di Nefrologia e Dialisi *Recruiting*
Milano,  ,  20122
Italy
Recruiting Claudio  Ponticelli -255034514

Prince of Wales Hospital *Recruiting*
Randwick,  ,  2031
Australia
Recruiting Bruce  Pussell 1.16129E+12

Carolinas Medical *Recruiting*
Charlotte,  North Carolina,  28232
United States
Recruiting Paul  Gores 704-355-6649

University of Rochester-Strong Memorial Hospital *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Martin  Zand 716-275-4517

Servicio de Nefrologia - Hospital Universitario reina Sofia *Recruiting*
Cordoba,  ,  14004
Spain
Recruiting Dr  Â  del Castillo 957 010318

University of Nebraska Medical Center *Recruiting*
Omaha,  Nebraska,  68198-2360
United States
Recruiting Vinay  Ranga 402-559-8390

Indiana University Medical Center *Recruiting*
Indianapolis,  Indiana,  46202-5250
United States
Recruiting Mahendra  Govani 317-278-3684

University of Tennessee-Memphis Health Science Center *Recruiting*
Memphis,  Tennessee,  38163
United States
Recruiting Maria  Egidi 901-484-4384

University Hospitals of Cleveland *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Donald  Hricik 216-844-5396

The Queen Elizabeth Hospital *Recruiting*
Woodville South,  ,  5011
Australia
Recruiting Graeme  Russ 1.16188E+12

Yale Univ School Of Medicine - Department Of Surgery *Recruiting*
New Haven,  Connecticut,  6520
United States
Recruiting Marc  Lorber 203-785-2565

University of Michigan Medical Center *Recruiting*
Ann Arbor,  Michigan,  48109-0364
United States
Recruiting Kathleen  Lake 313-936-4780

University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98195
United States
Recruiting Connie  Davis 206-548-4659

Maine Medical Center *Recruiting*
Portland,  Maine,  4102
United States
Recruiting John  Vella 207-775-2551

University of Alabama - Birmingham *Recruiting*
Birmingham,  Alabama,  35294
United States
Recruiting Bruce  Julian 205-934-1329

Cattedra Chirurgia Sostitutiva e Trapianti - Universita Cattolica del S. Cuore *Recruiting*
Rome,  ,  168
Italy
Recruiting Giuseppe  Nanni -630154430

Albany Medical College *Recruiting*
Albany,  New York,  12208
United States
Recruiting David  Conti 518-262-6422

Newark Beth Israel Medical Center - Renal Transplant *Recruiting*
Newark,  New Jersey,  7112
United States
Recruiting Sadanand  Palekar 973-923-7555

University of Maryland Medical Systems - Division of Nephrology *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Ravinder  Wali 410-328-5720

University of Iowa Hospitals & Clinics *Recruiting*
Iowa City,  Iowa,  52242
United States
Recruiting J.  Bertolatus 319-356-8225

Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425-0777
United States
Recruiting Dr.  Rajagopalan 803-792-7558

Service de Transplantation Renale et de Chirurgie des Glandes Endocrines *Recruiting*
BRUXELLES,  ,  B-1200
Belgium
Recruiting Professor  Squifflet +32.2.764.11.11

Medicinkliniken - Njurmedicinska Kliniken *Recruiting*
UPPSALA,  ,  SE-75185
Sweden
Recruiting Bengt  Fellström +46-18-611 00 00

Sharp Memorial Hospital *Recruiting*
San Diego,  California,  92123
United States
Recruiting Steven  Steinberg 619-541-6800

Boston University School of Medicine *Recruiting*
Boston,  Massachusetts,  02118-2393
United States
Recruiting Sang  Cho 617-638-8430

Servicio De Nefrologia (UTR) *Recruiting*
Barcelona,  ,  8907
Spain
Recruiting Jose  Grinyo 32607604

Washington University School of Medicine *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Daniel  Brennan 314-362-8351

University of Miami - Division of Nephrology *Recruiting*
Miami,  Florida,  33101
United States
Recruiting David  Roth 305-243-6251

Dallas Nephrology Asociates *Recruiting*
Dallas,  Texas,  75208
United States
Recruiting Karl  Brinker 214-366-6467


Additional Information:
Study ID Numbers:
  0468H1-316-US; 
Study Start Date: 
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038948

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