Pediatric Induction Therapy in Kidney Transplantation

NCT06087003 | Completed DMC FDA Drug

• 1 other identifier: PINK study
• Study Type: observational
• Target: 958
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this observational study is to compare the efficacy of two most commonly used induction therapy for the prevention of acute rejection (AR) after renal transplantation in children. The main question it aims to answer is: Is basiliximab (anti-CD25 monoclonal antibody) induction therapy effective and safe in preventing AR after kidney transplantation in children compared with anti-thymoglobulin polyclonal antibodies induction therapy? The transplant and follow-up data of participants will be retrospectively collected. Researchers will compare the rate of AR to see if basiliximab (anti-CD25 monoclonal antibody) induction therapy is a better option for certain pediatric kidney transplant recipients.

Conditions

Kidney Transplant Rejection; Pediatric Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Acute rejection (AR)

  The clinical diagnosis of AR is based on a significant increase in serum creatinine and the exclusion of other causes. The diagnosis of biopsy-confirmed AR is based on relevant histological changes.

  From baseline, kidney transplantation to data collection completion (June 30, 2023)

Secondary Outcomes (3)

• Cytomegalovirus (CMV) viremia

  From baseline, kidney transplantation to data collection completion (June 30, 2023)

• Pneumonia

  From baseline, kidney transplantation to data collection completion (June 30, 2023)

• Renal graft survival

  From baseline, kidney transplantation to data collection completion (June 30, 2023)

Study Arms (2)

Basilliximab induction group

Basiliximab was administered intravenously 4 hours before kidney graft reperfusion and at day 4 after kidney transplantation. For pediatric patients weighing \> 30kg, the dose of Basiliximab was 20mg, otherwise was 10mg.

Drug: Basiliximab Injection

rATG induction group

Rabbit antithymoglobulin (rATG) was administered intravenously during kidney transplantation (pre-reperfusion) and 1-2 days after transplantation. The dose was about 0.5-1 mg/kg per day.

Drug: rabbit ATG

Interventions

Basiliximab Injection DRUG

As an induction treatment for kidney transplantation

Also known as: Simulect

Basilliximab induction group

rabbit ATG DRUG

As an induction treatment for kidney transplantation

Also known as: Thymoglobuline

rATG induction group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will be selected from five centers with the highest number of pediatric kidney transplant cases in China, including Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Changhai Hospital Affiliated to Naval Medical University, the First Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Zhejiang University and the First Affiliated Hospital of Sun Yat-sen University.

You may qualify if:

• Receiving the kidney graft from a deceased donor
• Basiliximab or rATG induction therapy was used in perioperative period

You may not qualify if:

• Recipients with pre-transplant calculated panel reactive antibodies (cPRA) \>10%
• Recipients of combined liver, pancreas or heart transplantation
• No induction or other induction therapy was used in perioperative period
• Recieving the kidney graft from a living donor

Sponsors & Collaborators

• Gang Chen: lead
• Zhejiang University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Changhai Hospital: collaborator

Study Sites (5)

The First Affiliated Hospital of Sun Yat-sen University.

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

Changhai Hospital affiliated to Naval Military Medical University

Shanghai, China

Location

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430030, China

Location

Related Publications (8)

• Antunes H, Parada B, Tavares-da-Silva E, Carvalho J, Bastos C, Roseiro A, Nunes P, Figueiredo A. Pediatric Renal Transplantation: Evaluation of Long-Term Outcomes and Comparison to Adult Population. Transplant Proc. 2018 Jun;50(5):1264-1271. doi: 10.1016/j.transproceed.2018.02.089.

  PMID: 29880345 BACKGROUND

• Martinez-Mier G, Enriquez-De Los Santos H, Mendez-Lopez MT, Avila-Pardo SF, Budar-Fernandez LF, Gonzalez-Velazquez F. Rejection is a strong graft survival predictor in live donor pediatric renal transplantation using cyclosporine, mycophenolate mofetil, and steroids: 5-year outcomes in a single Mexican center. Transplant Proc. 2013 May;45(4):1442-4. doi: 10.1016/j.transproceed.2013.02.044.

  PMID: 23726592 BACKGROUND

• Crowson CN, Reed RD, Shelton BA, MacLennan PA, Locke JE. Lymphocyte-depleting induction therapy lowers the risk of acute rejection in African American pediatric kidney transplant recipients. Pediatr Transplant. 2017 Feb;21(1). doi: 10.1111/petr.12823. Epub 2016 Oct 3.

  PMID: 27699934 BACKGROUND

• Barton KT, Halani K, Galbiati S, Dandamudi R, Hmiel SP, Dharnidharka VR; NAPRTCS investigators. Late first acute rejection in pediatric kidney transplantation: A North American Pediatric Renal Trials and Collaborative Studies special study. Pediatr Transplant. 2021 Aug;25(5):e13953. doi: 10.1111/petr.13953. Epub 2020 Dec 22.

  PMID: 33350558 BACKGROUND

• Riad S, Jackson S, Chinnakotla S, Verghese P. Primary pediatric deceased-donor kidney transplant recipients outcomes by immunosuppression induction received in the United States. Pediatr Transplant. 2021 Aug;25(5):e13928. doi: 10.1111/petr.13928. Epub 2020 Dec 12.

  PMID: 33314638 BACKGROUND

• Mincham CM, Wong G, Teixeira-Pinto A, Kennedy S, Alexander S, Larkins N, Lim WH. Induction Therapy, Rejection, and Graft Outcomes in Pediatric and Adolescent Kidney Transplant Recipients. Transplantation. 2017 Sep;101(9):2146-2151. doi: 10.1097/TP.0000000000001577.

  PMID: 28832451 BACKGROUND

• Aw MM, Taylor RM, Verma A, Parke A, Baker AJ, Hadzic D, Muiesan P, Rela M, Heaton ND, Mieli-Vergani G, Dhawan A. Basiliximab (Simulect) for the treatment of steroid-resistant rejection in pediatric liver transpland recipients: a preliminary experience. Transplantation. 2003 Mar 27;75(6):796-9. doi: 10.1097/01.TP.0000054682.53834.EA.

  PMID: 12660504 BACKGROUND

• Goh HK, Lye WC. Biopsy-proven resolution of steroid-resistant acute rejection with basiliximab therapy in a renal allograft recipient. Transplant Proc. 2001 Nov-Dec;33(7-8):3213-4. doi: 10.1016/s0041-1345(01)02368-5. No abstract available.

  PMID: 11750379 BACKGROUND

MeSH Terms

Interventions

Basiliximab; thymoglobulin; Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immune Sera; Biological Products; Complex Mixtures

Study Officials

• Gang Chen, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 17, 2023
• Study Start: March 3, 2013
• Primary Completion: July 27, 2022
• Study Completion: September 30, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)