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

September 13, 2023 updated by: University of Miami

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Division of Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of biopsy-proven acute rejection at 1 year.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient and graft survival
Time Frame: 1 and 3 years
1 and 3 years
Incidence of biopsy-proven chronic allograft nephropathy.
Time Frame: 1 and 3 years
1 and 3 years
Levels of lymphoid cell subsets.
Time Frame: 1 and 3 years
1 and 3 years
Incidence of adverse reactions, for example: Infections, Malignancies, Thromboembolic events.
Time Frame: 1 and 3 years
1 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: George W Burke, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimated)

May 21, 2008

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#20010704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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