Clinical trial NCT00183248 (phase 1/phase 2, status: completed)
Conditions: kidney transplantation, kidney disease, kidney failure
ICD codes: N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0, I12.9, N18.9, Q61.9, I12.0, D63.1, N18.1, N18.5, N19, T86.12, N17.8, N17.9, O90.4, N99.0, N17.0
Drugs: alemtuzumab, mycophenolate mofetil, sirolimus, tacrolimus
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Weight greater than 40 kg (88.2 lbs)

          -  Will be receiving a living-related (1-haplotype-matched donor/recipient) primary
             kidney allograft

          -  Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch
             (1-haplotype-matched donor/recipient pairs with a minimum of 1 HLA DR 1A and 1B locus
             in common and panel-reactive antibodies [PRA] of less than 10%)

          -  Normal echocardiogram (ECG) with an ejection fraction of greater than 50%

          -  Received full course of vaccination for hepatitis B virus (HBV), completed at least 6
             weeks before transplantation, OR has naturally acquired immunity

          -  Willing to comply with the study visits

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  Previously received or is receiving an organ transplant other than a kidney

          -  Receiving an ABO (blood type) incompatible donor kidney

          -  Human Immunodeficiency Virus (HIV) infected

          -  Antibody positive for hepatitis C virus (HCV)

          -  Surface antigen positive for hepatitis B virus (HBV)

          -  Recipient or donor is positive for tuberculosis (TB), under treatment for suspected
             TB, or previously exposed to TB (positive Mantoux test)

          -  Current cancer or a history of cancer within the 5 years prior to study entry.
             Patients who have had successfully treated nonmetastatic basal or squamous cell
             carcinoma of the skin or carcinoma in situ of the cervix are not excluded.

          -  Significant liver disease, defined as having continuously elevated aspartate
             aminotransferase (AST SGOT) or alanine aminotransferase (ALT SGPT) levels greater than
             3 times the upper value of the normal range within 28 days prior to study entry

          -  Uncontrolled concomitant infections, severe diarrhea, vomiting, active upper
             gastrointestinal tract malabsorption, active peptic ulcer, or any other unstable
             medical condition that could interfere with this study

          -  Currently receiving an investigational drug or received an investigational drug within
             30 days prior to transplant

          -  Currently receiving any immunosuppressive agent

          -  Anticipated contraindication to taking medications orally or via nasogastric tube by
             the morning of Day 2 following completion of the transplant procedure

          -  Require certain medications

          -  Known hypersensitivity to any of the study medications, thymoglobulin daclizumab, or
             corticosteroids

          -  Certain screening laboratory values. More information on this criterion can be found
             in the protocol.

          -  Any form of substance abuse, psychiatric disorder, or other condition that, in opinion
             of the investigator, may interfere with the study

          -  Anticipated contraindication to tacrolimus administration for longer than 5 days
             post-transplant

          -  Currently undergoing peritoneal dialysis

          -  PRA value less than 10% at any time prior to study entry

          -  Graves disease. Patients with Graves disease adequately treated with radioiodine
             ablative therapy are not excluded.

          -  Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) negative kidney recipient receiving
             a kidney from a CMV or EBV positive donor

          -  Pregnancy or breastfeeding