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

NCT00681343 | Completed Phase 4 DMC

• 1 other identifier: IRB#20010704
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Living-Donor Kidney Transplant

Keywords

Randomized; study; effectiveness/toxicity; induction therapy; recipients

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (4)

• Patient and graft survival

  1 and 3 years

• Incidence of biopsy-proven chronic allograft nephropathy.

  1 and 3 years

• Levels of lymphoid cell subsets.

  1 and 3 years

• Incidence of adverse reactions, for example: Infections, Malignancies, Thromboembolic events.

  1 and 3 years

Study Arms (3)

A

EXPERIMENTAL

Thymoglobulin Induction

Drug: Thymoglobulin

B

EXPERIMENTAL

Campath-1H Induction

Drug: Campath-1H

C

EXPERIMENTAL

Daclizumab Induction

Drug: Daclizumab

Interventions

Thymoglobulin DRUG

Induction

A

Campath-1H DRUG

Induction

Also known as: Alemtuzumab

B

Daclizumab DRUG

Induction

Also known as: Zenapax

C

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 16-65 years
• Weight \> 40 kg
• Primary renal allograft: living related (non HLA identical) and unrelated donor
• Negative standard cross-match for T-cells. All donor-recipient pairs matched for a minimum of 1 HLA DR antigen. (Standard at our center)
• 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
• Males and females are to be studied equivalently as they become available for transplantation using these criteria.

You may not qualify if:

• Patient has previously received or is receiving an organ transplant other than a kidney.
• Patient is receiving an ABO incompatible donor kidney.
• Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
• 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.
• 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.
• 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.
• Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
• Patient will be receiving any immunosuppressive agent other that those prescribed in the study.
• 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).
• Patient is receiving or may require warfarin, fluvastatin or herbal supplements during the study.
• Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
• Patient has a known hypersensitivity to Tacrolimus, Campath-1H, Thymoglobulin, Daclizumab (Zenapax®), Sirolimus, MMF or corticosteroids.
• Patient is pregnant or lactating.
• 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.
• Patient is unlikely to comply with the visits scheduled in the protocol.

Sponsors & Collaborators

• University of Miami: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of Miami Division of Transplantation

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 24477186 DERIVED

MeSH Terms

Interventions

thymoglobulin; Alemtuzumab; Daclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George W Burke

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: September 1, 2002
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2007
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

US (1)