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

NCT03006419 | Completed Phase 4 DMC

• 1 other identifier: R-2016-3001-61
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Kidney Transplant Rejection; Kidney Transplant; Complications

Keywords

kidney transplantation; induction; thymoglobulin; basiliximab; acute rejection; graft loss

Outcome Measures

Primary Outcomes (1)

• Biopsy proven acute rejection

  Acute rejection described by Banff category

  12 months following transplantation

Secondary Outcomes (7)

• Delayed graft function

  12 months following transplantation

• Slow graft function

  12 months following transplantation

• Infections

  12 months following transplantation

• Hospital admissions

  12 months following transplantation

• Graft function

  12 months following transplantation

Study Arms (2)

Group A (Basiliximab group)

ACTIVE COMPARATOR

Basiliximab (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.

Drug: Basiliximab

B (Low-dose Thymoglobulin group)

EXPERIMENTAL

Thymoglobulin 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.

Drug: Thymoglobulin

Interventions

Basiliximab DRUG

Standard induction therapy

Also known as: Simulect

Group A (Basiliximab group)

Thymoglobulin DRUG

Induction therapy

Also known as: rATG

B (Low-dose Thymoglobulin group)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Umae Hospital Especialidades 14 Adolfo Ruiz Cortines

Veracruz, 91897, Mexico

Location

Related Publications (5)

• 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.

  PMID: 21440733 BACKGROUND

• 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.

  PMID: 21716186 BACKGROUND

• 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.

  PMID: 17093248 RESULT

• 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.

  PMID: 22850297 RESULT

• 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.

  PMID: 16699456 RESULT

MeSH Terms

Interventions

Basiliximab; thymoglobulin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gustavo Martinez-Mier, MD

  Jefe de División, UMAE 189, Veracruz, Veracruz

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: December 1, 2016
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 15, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)