Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Deceased Donor Renal Transplantation

Renal Transplantation Clinical Trial

Official title:

Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Cadaver Donor Renal Transplantation: A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685061
• Other study ID #: IRB#20020213
• Status: Completed
• Phase: Phase 4
• Start date: November 2002
• Est. completion date: September 2005

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first cadaver (CAD) kidneys.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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 cadaver renal allograft

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 (HIV), or 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 and/or is taking or has been taking 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, mycophenolate 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.

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Thymoglobulin
Induction
• Campath-1H
Induction
• Daclizumab
Induction

Locations

Country	Name	City	State
United States	University of Miami Division of Transplantation	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ciancio G, Burke GW, Gaynor JJ, Carreno MR, Cirocco RE, Mathew JM, Mattiazzi A, Cordovilla T, Roth D, Kupin W, Rosen A, Esquenazi V, Tzakis AG, Miller J. A randomized trial of three renal transplant induction antibodies: early comparison of tacrolimus, my — View Citation

Ciancio G, Burke GW, Gaynor JJ, Roth D, Kupin W, Rosen A, Cordovilla T, Tueros L, Herrada E, Miller J. A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of biopsy-proven acute rejection at 1 year.		1 year
Secondary	One-year and 3 year patient and graft survival.		1 and 3 years