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Kidney Transplant RejectionPINKNCT06087003

Pediatric Induction Therapy in Kidney Transplantation

An observational study of Kidney Transplant Rejection and Pediatric Kidney Disease, run by Gang Chen at 5 sites in China.

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

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. Read more about this study

Who is it for?
Ages 1 month to 18 years
What is being tested?
Basiliximab Injection and rabbit ATG
Type of treatment
Injection or infusion
How many people
958 participants
Where
5 sitesChina
Study dates
3 Mar 2013to 30 Sep 2023
Phase
Observational
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 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • The First Affiliated Hospital of Sun Yat-sen University.

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou

  • Changhai Hospital affiliated to Naval Military Medical University

    Shanghai

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

    Wuhan, 430030

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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

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?

Read more

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.

Being tested
Basiliximab Injection, rabbit ATG

What participants receive

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

  • Basiliximab InjectionDrug

    Also called Simulect

    As an induction treatment for kidney transplantation

  • rabbit ATGDrug

    Also called Thymoglobuline

    As an induction treatment for kidney transplantation

Study groups in NCT06087003
Study groupRoleWhat they receive
Basilliximab induction groupBasiliximab 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.
Receives: Drug: Basiliximab Injection
rATG induction groupRabbit 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.
Receives: Drug: rabbit ATG

What is being measured

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

  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.

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

Secondary outcomes (3)

  1. Cytomegalovirus (CMV) viremia

    The serum CMV is greater than 500 copies/ml

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

  2. Pneumonia

    Any pneumonia that showed the presence of lesion and required hospitalization

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

  3. Renal graft survival

    The estimated glomerular filtration rate (eGFR) of patient is >15 ml/min/1.73m2

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

Timeline

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

  1. First posted17 Oct 2023
  2. Study start3 Mar 2013
  3. Primary completion27 Jul 2022
  4. Study completion30 Sep 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
958 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087003
Sponsor's protocol ID
PINK study
Acronym
PINK
Status last verified
Oct 2023
First submitted
8 Oct 2023
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29880345

  • 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.

    PubMed 23726592

  • 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.

    PubMed 27699934

  • 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.

    PubMed 33350558

  • 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.

    PubMed 33314638

  • 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.

    PubMed 28832451

  • 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.

    PubMed 12660504

  • 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.

    PubMed 11750379

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Rejection and Pediatric Kidney Disease, run by Gang Chen at 5 sites in China.

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 2 inclusion and 4 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 17 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 5 sites in China. 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.

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?

Acute rejection (AR) (time frame: From baseline, kidney transplantation to data collection completion (June 30, 2023)). 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 NCT06087003, which also lists 8 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 17 Oct 2023.

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