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Renal TransplantationPhase 4NCT00685061

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

A Phase 4 study testing Thymoglobulin, Campath-1H and Daclizumab in people with Renal Transplantation, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Renal Transplantation
What is being tested?
Thymoglobulin, Campath-1H and Daclizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
Nov 2002to Sep 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
  • If tacrolimus cannot be instituted for longer than 5 days postoperatively.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Division of Transplantation

    Miami, Florida, 33136

Other trials in United States

About this study

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

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.

Being tested
Thymoglobulin, Campath-1H, Daclizumab
Keywords
Adult, primary deceased donor kidney transplant recipients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThymoglobulinDrug

    Induction

  • Campath-1HDrug

    Also called Alemtuzumab

    Induction

  • DaclizumabDrug

    Also called Zenapax

    Induction

Study groups in NCT00685061
Study groupRoleWhat they receive
AExperimentalThymoglobulin Induction
Receives: Drug: Thymoglobulin
BExperimentalCampath-1H Induction
Receives: Drug: Campath-1H
CExperimentalDaclizumab Induction
Receives: Drug: Daclizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (1)

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

    Measured: 1 and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2008 (estimated)
  2. Study startNov 2002
  3. Primary completionSep 2004
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685061
Sponsor's protocol ID
IRB#20020213
Status last verified
Oct 2023
First submitted
23 May 2008
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16123718

  • 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.

    PubMed 18339140

  • 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.

    PubMed 24477186

  • 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.

    PubMed 21981661

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Thymoglobulin, Campath-1H and Daclizumab in people with Renal Transplantation, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of biopsy-proven acute rejection at 1 year. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685061, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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