ID

43089

Description

ODM derived from http://clinicaltrials.gov/show/NCT01363752

Link

http://clinicaltrials.gov/show/NCT01363752

Keywords

  1. 4/11/13 4/11/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT01363752 Kidney Transplantation

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
Exclusion Criteria
Receiving or having previously received an organ transplant other than a kidney
Cold ischemia time of the donor kidney > 30 hours
Panel-reactive antibody
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Pregnant woman or breast-feeding mother
Subject or donor known to be HIV positive
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
Unlikely to comply with the visits scheduled in the protocol

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