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Kidney Transplant RejectionPhase 4NCT03006419

Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients

A Phase 4 study testing Basiliximab and Thymoglobulin in people with Kidney Transplant Rejection and Kidney Transplant; Complications, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

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

Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Basiliximab and Thymoglobulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteMexico
Study dates
1 Dec 2016to 30 Jul 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female graft recipients older than 18 years of age.
  • Informed consent to participate in the study.
  • First living donor kidney transplant recipient.
  • Negative pregnancy test if female participant

Who cannot join

  • Second or more kidney transplant.
  • Multiple organ transplant recipients.
  • ABO incompatibility or positive cross-over test prior to transplantation.
  • Antibody Reactive Panel (PRA) > 30%.
  • Positive specific donor antibodies (DSA).
  • Human immunodeficiency virus (HIV) positive patients.
Show all 12Show fewer
  • HBsAg or HCV positive.
  • Severe lung disorders.
  • Severe allergies receiving treatment that prevent patient's rRTAG administration.
  • Leukocyte count below 2000 / mm3.
  • Platelet count below 75,000 / mm3.
  • History of malignant disease of any organ system (except skin basal cell carcinoma) within the last 5 years, regardless of local recurrence or metastasis.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Umae Hospital Especialidades 14 Adolfo Ruiz Cortines

    Veracruz, 91897

Other trials in Mexico

About this study

Official title: Basiliximab vs Reduced Dose Rabbit Antithymocyte Globulin (rRTAG): Evaluation of Efficacy and Safety Outcomes in Low Immunological Risk Living Donor Kidney Transplant: 12-month Randomized Controlled Study

Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction

Read the detailed description

Introduction: The TAILOR study in living donor kidney transplantation demonstrated a 98% one year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in 93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR rate in rATG (thymoglobulin) (p <0.05) and better serum creatinine in 3 and 5 years. The aim of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction.

Material and methods: Prospective randomized study of patients undergoing renal transplantation who wish to participate. 100 patients who meet the inclusion and exclusion criteria at the time of transplantation will be randomized

Experimental and reference therapy:

Group A: Induction with Basiliximab 20 mg IV day 0 and day 4 Group B: rATG (Thymoglobulin) 1 mg / kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg / kg day. According to protocol administration, if there are conditions to delay administration (WBC<2000 / mm3 and / or platelets <75,000 / mm3) (17), administration may be postponed until day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and steroids

Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute rejection episodes infections hospitalizations adverse events graft loss death

Being tested
Basiliximab, Thymoglobulin
Keywords
kidney transplantation, induction, thymoglobulin, basiliximab, acute rejection, graft loss

What participants receive

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

  • BasiliximabDrug

    Also called Simulect

    Standard induction therapy

  • ThymoglobulinDrug

    Also called rATG

    Induction therapy

Study groups in NCT03006419
Study groupRoleWhat they receive
Group A (Basiliximab group)Active comparatorBasiliximab (Simulect) induction therapy: 20 mg IV at day of transplant (to be administered 2 hours prior to transplant and up to 4 hours after transplant) and second dosage (20 mg) at fourth day after kidney transplantation.
Receives: Drug: Basiliximab
B (Low-dose Thymoglobulin group)ExperimentalThymoglobulin induction therapy (1 mg/kg rounded by 25 mg increments) at day of transplant followed by same dosage (1 mg/kg rounded by 25 mg increments) during day 1 and day 2 after transplant in order to complete 3 mg/kg accumulated dose.
Receives: Drug: Thymoglobulin

What is being measured

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

  1. Biopsy proven acute rejection

    Acute rejection described by Banff category

    Measured: 12 months following transplantation

Secondary outcomes (7)

  1. Delayed graft function

    Dialysis during first week of transplantation

    Measured: 12 months following transplantation

  2. Slow graft function

    Creatinine clearance < 50% pretransplant during first week of transplantation

    Measured: 12 months following transplantation

  3. Infections

    Presence of a positive culture of any microorganism in presence of clinical symptoms

    Measured: 12 months following transplantation

  4. Hospital admissions

    Admission to the hospital for at least 24 hours

    Measured: 12 months following transplantation

  5. Graft function

    Creatinine clearance measured by MDRD-4

    Measured: 12 months following transplantation

  6. Graft loss

    Return to dialysis

    Measured: 12 months following transplantation

  7. Patient survival

    Patient Death

    Measured: 12 months following transplantation

Timeline

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

  1. First posted30 Dec 2016 (estimated)
  2. Study start1 Dec 2016
  3. Primary completion30 Jul 2019
  4. Study completion30 Jul 2019

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03006419
Sponsor's protocol ID
R-2016-3001-61
Status last verified
Dec 2018
First submitted
27 Dec 2016
Last updated
15 Nov 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No IPD sharing plan

Publications

  • Laftavi MR, Alnimri M, Weber-Shrikant E, Kohli R, Said M, Patel S, Pankewycz O. Low-dose rabbit antithymocyte globulin versus basiliximab induction therapy in low-risk renal transplant recipients: 8-year follow-up. Transplant Proc. 2011 Mar;43(2):458-61. doi: 10.1016/j.transproceed.2011.01.035.

    PubMed 21440733

  • Schenker P, Ozturk A, Vonend O, Kruger B, Jazra M, Wunsch A, Kramer B, Viebahn R. Single-dose thymoglobulin induction in living-donor renal transplantation. Ann Transplant. 2011 Apr-Jun;16(2):50-8. doi: 10.12659/aot.881865.

    PubMed 21716186

  • Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068.

    PubMed 17093248

  • Gaber AO, Matas AJ, Henry ML, Brennan DC, Stevens RB, Kapur S, Ilsley JN, Kistler KD, Cosimi AB; Thymoglobulin Antibody Immunosuppression in Living Donor Recipients Investigators. Antithymocyte globulin induction in living donor renal transplant recipients: final report of the TAILOR registry. Transplantation. 2012 Aug 27;94(4):331-7. doi: 10.1097/TP.0b013e31825a7d1f.

    PubMed 22850297

  • Hardinger KL, Schnitzler MA, Koch MJ, Labile E, Stirnemann PM, Miller B, Enkvetchakul D, Brennan DC. Thymoglobulin induction is safe and effective in live-donor renal transplantation: a single center experience. Transplantation. 2006 May 15;81(9):1285-9. doi: 10.1097/01.tp.0000209825.91632.ea.

    PubMed 16699456

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Basiliximab and Thymoglobulin in people with Kidney Transplant Rejection and Kidney Transplant; Complications, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

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 4 inclusion and 12 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 15 Nov 2019. 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 Mexico. 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?

Biopsy proven acute rejection (time frame: 12 months following transplantation). 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 NCT03006419, which also lists 5 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 15 Nov 2019.

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