Pediatric Induction Therapy in Kidney Transplantation

Kidney Transplant Rejection Clinical Trial

— PINK  

Official title:

Induction Therapy of Thymoglobulin Versus Basiliximab in the Prevention of Acute Rejection After Pediatric Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06087003
• Other study ID #: PINK study
• Status: Completed
• Start date: March 3, 2013
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 958
• Est. completion date: September 30, 2023
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Receiving the kidney graft from a deceased donor

• Basiliximab or rATG induction therapy was used in perioperative period

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Transplant Rejection
• Pediatric Kidney Disease

Intervention

Drug:
• Basiliximab Injection
As an induction treatment for kidney transplantation
• rabbit ATG
As an induction treatment for kidney transplantation

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University.	Guangzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University	Hangzhou
China	Changhai Hospital affiliated to Naval Military Medical University	Shanghai
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (5)

Lead Sponsor	Collaborator
Gang Chen	Changhai Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Zhejiang University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cytomegalovirus (CMV) viremia	The serum CMV is greater than 500 copies/ml	From baseline, kidney transplantation to data collection completion (June 30, 2023)
Secondary	Pneumonia	Any pneumonia that showed the presence of lesion and required hospitalization	From baseline, kidney transplantation to data collection completion (June 30, 2023)
Secondary	Renal graft survival	The estimated glomerular filtration rate (eGFR) of patient is >15 ml/min/1.73m2	From baseline, kidney transplantation to data collection completion (June 30, 2023)