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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT00685061
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Duration (Months): 34
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Thymoglobulin; Drug: Campath-1H; Drug: Daclizumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2002
• Actual Primary Completion Date: Sep 1, 2004
• Actual Study Completion Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Thymoglobulin Induction	Drug: Thymoglobulin; Induction
Experimental: B Campath-1H Induction	Drug: Campath-1H; Induction; Other Names: Alemtuzumab
Experimental: C Daclizumab Induction	Drug: Daclizumab; Induction; Other Names: Zenapax

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of biopsy-proven acute rejection at 1 year. [1 year]

Secondary Outcome Measures

1. One-year and 3 year patient and graft survival. [1 and 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Division of Transplantation	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00685061
• Other Study ID Numbers: IRB#20020213
• First Posted: May 28, 2008
• Last Update Posted: May 28, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Adult, primary deceased donor kidney transplant recipients
• Additional relevant MeSH terms: Alemtuzumab; Thymoglobulin; Daclizumab

Study Results

No Results Posted as of May 28, 2008