NCT00685061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

May 23, 2008

Last Update Submit

October 16, 2023

Conditions

Renal Transplantation

Keywords

Adult, primary deceased donor kidney transplant recipients

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (1)

  • One-year and 3 year patient and graft survival.

    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

ThymoglobulinDRUG

Induction

A
Campath-1HDRUG

Induction

Also known as: Alemtuzumab
B
DaclizumabDRUG

Induction

Also known as: Zenapax
C

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (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 cadaver renal allograft
  • 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 (HIV), or 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 and/or is taking or has been taking 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, mycophenolate 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Division of Transplantation

Miami, Florida, 33136, United States

Location

Related Publications (4)

  • 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, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring. Transplantation. 2005 Aug 27;80(4):457-65. doi: 10.1097/01.tp.0000165847.05787.08.

    PMID: 16123718RESULT

  • 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 of follow-up. Clin Transplant. 2008 Mar-Apr;22(2):200-10. doi: 10.1111/j.1399-0012.2007.00774.x.

    PMID: 18339140RESULT

  • 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: 24477186DERIVED

  • Ciancio G, Gaynor JJ, Sageshima J, Roth D, Kupin W, Guerra G, Tueros L, Zarak A, Hanson L, Ganz S, Chen L, Ruiz P, Livingstone AS, Burke GW 3rd. Machine perfusion following static cold storage preservation in kidney transplantation: donor-matched pair analysis of the prognostic impact of longer pump time. Transpl Int. 2012 Jan;25(1):34-40. doi: 10.1111/j.1432-2277.2011.01364.x. Epub 2011 Oct 8.

    PMID: 21981661DERIVED

MeSH Terms

Interventions

thymoglobulinAlemtuzumabDaclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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 23, 2008

First Posted

May 28, 2008

Study Start

November 1, 2002

Primary Completion

September 1, 2004

Study Completion

September 1, 2005

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

US(1)