Clinical trial NCT00681343: Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Living Donor Renal Transplantation
Official title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Living-Donor Kidney Transplant
Keywords: Randomized
study
effectiveness/toxicity
induction therapy
recipients
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2008-05-21
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression


Eligibility criteria: Inclusion Criteria:

1. Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (36 months). Parent or legal guardian must provide written consent for patients \<18 years of age.
2. Age 16-65 years
3. Weight \> 40 kg
4. Primary renal allograft: living related (non HLA identical) and unrelated donor
5. Negative standard cross-match for T-cells. All donor-recipient pairs matched for a minimum of 1 HLA DR antigen. (Standard at our center)
6. Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception for 3 months following discontinuation of Thymoglobulin or Campath-1H
7. Males and females are to be studied equivalently as they become available for transplantation using these criteria.

Exclusion Criteria:

1. Patient has previously received or is receiving an organ transplant other than a kidney.
2. Patient is receiving an ABO incompatible donor kidney.
3. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
4. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
5. Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of this center.
6. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
7. Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
8. Patient will be receiving any immunosuppressive agent other that those prescribed in the study.
9. Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e. skin closure).
10. Patient is receiving or may require warfarin, fluvastatin or herbal supplements during the study.
11. Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
12. Patient has a known hypersensitivity to Tacrolimus, Campath-1H, Thymoglobulin, Daclizumab (Zenapax®), Sirolimus, MMF or corticosteroids.
13. Patient is pregnant or lactating.
14. Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count \<4000/mm3; platelet count \<100,000/mm3; fasting triglycerides \>400 mg/dl (\>4.6 mmol/L); fasting total cholesterol \>300 mg/dl (\>7.8 mmol/L); fasting HDL-cholesterol \<30 mg/dl; fasting LDL-cholesterol \>200mg/dl.
15. Patient is unlikely to comply with the visits scheduled in the protocol.
16. Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
17. If tacrolimus cannot be instituted for longer than 5 days postoperatively.

Primary outcomes:
measure: Incidence and severity of biopsy-proven acute rejection at 1 year.
timeFrame: 1 year
Secondary outcomes:
measure: Patient and graft survival
timeFrame: 1 and 3 years
measure: Incidence of biopsy-proven chronic allograft nephropathy.
timeFrame: 1 and 3 years
measure: Levels of lymphoid cell subsets.
timeFrame: 1 and 3 years
measure: Incidence of adverse reactions, for example: Infections, Malignancies, Thromboembolic events.
timeFrame: 1 and 3 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Division of Transplantation
state: Florida
Study officials:
affiliation: University of Miami
name: George W Burke
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciancio G, Gaynor JJ, Guerra G, Sageshima J, Chen L, Mattiazzi A, Roth D, Kupin W, Tueros L, Flores S, Hanson L, Vianna R, Burke GW 3rd. Randomized trial of three induction antibodies in kidney transplantation: long-term results. Transplantation. 2014 Jun 15;97(11):1128-38. doi: 10.1097/01.TP.0000441089.39840.66.