Clinical trial NCT00078559 (phase 1/phase 2, status: completed)
Conditions: kidney transplantation, kidney disease
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
Drugs: alemtuzumab, sirolimus, tacrolimus, methylprednisolone (or equivalent), acetaminophen, diphenhydramine, trimethoprim (tmp)/sulfa (bactrim, septra), valgancyclovir, acyclovir, pentamidine, clotrimazole, nystatin
SMILES: 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, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C, CC1=CC(O)=CC(C)=C1Cl, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1, COC1=CC(CC2=CN=C(N)N=C2N)=CC(OC)=C1OC, NC1=NC(=O)C2=C(N1)N(COCCO)C=N2, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O, ClC1=CC=CC=C1C(N1C=CN=C1)(C1=CC=CC=C1)C1=CC=CC=C1, C[C@H]1OC(OC2CC(O)C(C(O)CC(=O)CC(O)C(O)CCC(O)CC(O)CC(O)CC(=O)OC(C)C(C)C(O)C(C)\C=C\C=C\CC\C=C\C=C\C=C\C=C\2)C(O)=O)[C@@H](O)[C@@H](N)[C@@H]1O
Eligibility criteria:

        Inclusion Criteria

          -  Kidney transplant with primary cadaveric or non-Human Leukocyte Antigen
             (HLA)-identical living donor kidney (0-3 HLA-antigen mismatch)

          -  Receiving only a kidney and no other organs

          -  Able to take medications by mouth

          -  Willing to use acceptable methods of contraception

        Exclusion Criteria

          -  Received HLA-identical living-donor kidney transplant

          -  HLA-antigen mismatch greater than 3

          -  Panel reactive antibody (PRA) value greater than 10% at any time prior to enrollment

          -  Received a non-heart-beating donor allograft

          -  Received a kidney from a donor who is greater than 60 years of age

          -  End-stage Renal Disease (ESRD) due to Focal Segmental Glomulerosclerosis (FSGS)

          -  Previous kidney transplant

          -  Received multiorgan transplant

          -  Concomitant systemic corticosteroid therapy for other medical diseases

          -  Known hypersensitivity to alemtuzumab, tacrolimus, methylprednisolone, or sirolimus

          -  Human Immunodeficiency Virus (HIV) infected

          -  Hepatitis C virus infected

          -  Positive for hepatitis B surface antigen

          -  Received dual or en-bloc pediatric kidneys

          -  Anti-human Globulin (AHG) or T cell crossmatch positive

          -  Investigational drug within 6 weeks of study entry

          -  Known clinically significant cardiovascular or cerebrovascular disease

          -  Previous or current history of cancer or lymphoma. Patients with adequately treated
             basal or squamous cell skin carcinoma are not excluded.

          -  Clinically significant coagulopathy or a requirement for chronic anti-coagulation
             therapy precluding biopsy

          -  Cytomegalovirus (CMV)-negative recipient, if received kidney is from a CMV-positive
             donor

          -  History of a psychological illness or condition that, in the opinion of the
             investigator, may interfere with the study

          -  Graves disease. Patients who have been previously adequately treated with radioiodine
             ablative therapy are not excluded.

          -  Active systemic infections

          -  Platelets less than 100,000 cells/mm^3 at study entry

          -  Pregnant or breastfeeding