Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
NCT ID: NCT00078559
Last Updated: 2018-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2003-11-30
2010-02-28
Brief Summary
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Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs.
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Detailed Description
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This study will last up to 4 years. Participants will undergo kidney transplantation on Day 0 and will receive intravenous doses of alemtuzumab, acetaminophen, and diphenhydramine on Days 0, 1, and 2, as well as methylprednisolone on Day 0. After transplant, patients will receive up to 10 days of valganciclovir or acyclovir. Participants will take tacrolimus daily by mouth for at least 60 days after transplant and sirolimus daily by mouth for at least 12 months after transplant. As part of opportunistic infection (OI) prophylaxis, participants will also take sulfamethoxazole-trimethoprim by mouth 3 times a week, valganciclovir or acyclovir for up to 10 days post-transplant, and clotrimazole or nystatin by mouth for at least 3 months post-transplant.
There will be a minimum of 62 study visits spread out over 4 years after transplant. Vital signs measurement, adverse event and OI reporting, medication history, physical exam, and blood collection will occur at selected visits. Sirolimus withdrawal will begin when a participant meets certain study criteria. The withdrawal process will occur over a minimum of 3 months at an approximate rate of 33% of the pre-withdrawal dose per month. Participants eligible for sirolimus withdrawal will undergo several kidney biopsies, including one 2 weeks prior to the start of withdrawal, 6 and 12 months after completion of withdrawal, 1 year after study enrollment, and annually thereafter.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alemtuzumab
Alemtuzumab
30mg intravenous infusion on days 0 (transplant), 1, and 2
Sirolimus
2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year
Tacrolimus
2mg orally twice daily, on days 1-60
Kidney transplant
Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
Methylprednisolone (or equivalent)
250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab
Acetaminophen
650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
Diphenhydramine
25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
Trimethoprim (TMP)/Sulfa (Bactrim, Septra)
1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.
Valgancyclovir
Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance
Acyclovir
400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.
Pentamidine
300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa
Clotrimazole
10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)
Nystatin
500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)
Interventions
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Alemtuzumab
30mg intravenous infusion on days 0 (transplant), 1, and 2
Sirolimus
2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year
Tacrolimus
2mg orally twice daily, on days 1-60
Kidney transplant
Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
Methylprednisolone (or equivalent)
250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab
Acetaminophen
650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
Diphenhydramine
25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
Trimethoprim (TMP)/Sulfa (Bactrim, Septra)
1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.
Valgancyclovir
Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance
Acyclovir
400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.
Pentamidine
300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa
Clotrimazole
10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)
Nystatin
500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)
Eligibility Criteria
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Inclusion Criteria
* Receiving only a kidney and no other organs
* Able to take medications by mouth
* Willing to use acceptable methods of contraception
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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A. D'jamali, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Immune Tolerance Network (ITN)
Locations
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University of Wisconsin - Department of Medicine
Madison, Wisconsin, United States
Countries
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References
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First MR. Tacrolimus based immunosuppression. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S25-31.
Gourishankar S, Turner P, Halloran P. New developments in immunosuppressive therapy in renal transplantation. Expert Opin Biol Ther. 2002 Jun;2(5):483-501. doi: 10.1517/14712598.2.5.483.
Watson CJ, Bradley JA, Friend PJ, Firth J, Taylor CJ, Bradley JR, Smith KG, Thiru S, Jamieson NV, Hale G, Waldmann H, Calne R. Alemtuzumab (CAMPATH 1H) induction therapy in cadaveric kidney transplantation--efficacy and safety at five years. Am J Transplant. 2005 Jun;5(6):1347-53. doi: 10.1111/j.1600-6143.2005.00822.x.
Related Links
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Click here for the Immune Tolerance Network Web site
Related Info
Other Identifiers
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H-2003-0435
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT ITN013ST
Identifier Type: -
Identifier Source: org_study_id
NCT00585130
Identifier Type: -
Identifier Source: nct_alias
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