NCT04292418

Brief Summary

Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

February 29, 2020

Last Update Submit

February 29, 2020

Conditions

Rejection Acute Renal

Outcome Measures

Primary Outcomes (1)

  • predictors of rejection

    detect the potentially predictors of rejection in pediatric kidney transplant recipient

    2 year

Secondary Outcomes (1)

  • measure corrected tacrolimus level and mycophenolic acid

    2 year

Study Arms (2)

study group 1

(rejector group )include Paediatric living donor kidney transplant recipients (aged 4-18 years) at least 35 child recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \[mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the study group 1 measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test

Drug: Tacrolimus capsule , mycophenolic acid

study group 2

the second group (non rejector group ) include Paediatric living donor kidney transplant recipients (aged 4-18 years) recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \[mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the studied group at least 35 child measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test in the study group 2

Drug: Tacrolimus capsule , mycophenolic acid

Interventions

Tacrolimus capsule , mycophenolic acidDRUG

measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2

study group 1study group 2

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Paediatric living donor kidney transplant recipients (aged 1-18 years)

You may qualify if:

  • Paediatric living donor kidney transplant recipients (aged 1-18 years)
  • patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \[mycophenolate mofetil (MMF) and steroids
  • recipients with biopsy proven acute rejection in the studied group.

You may not qualify if:

  • patients on cyclosporine
  • patients with active infection and dehydration
  • Patients who received multiorgan transplantation Non cooperative patient will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Bulut IK, Taner S, Keskinoglu A, Sezer TO, Kabasakal C. Pediatric Kidney Transplantation in Patients With Urologic Anomalies. Transplant Proc. 2019 Sep;51(7):2257-2261. doi: 10.1016/j.transproceed.2019.01.155. Epub 2019 Aug 7.

    PMID: 31400969RESULT

  • Tamain M, Sayegh J, Lionet A, Grimbert P, Philipponnet C, Hazzan M, Augusto JF, Buchler M, Merlin E, Kosmadakis G, Tiple A, Pereira B, Garrouste C, Heng AE. Extracorporeal photopheresis for the treatment of graft rejection in 33 adult kidney transplant recipients. Transfus Apher Sci. 2019 Aug;58(4):515-524. doi: 10.1016/j.transci.2019.06.031. Epub 2019 Jul 22.

    PMID: 31383541RESULT

  • Park WY, Paek JH, Jin K, Park SB, Han S. Long-term Clinical Significance of Tacrolimus Trough Level at the Early Period After Kidney Transplantation. Transplant Proc. 2019 Oct;51(8):2643-2647. doi: 10.1016/j.transproceed.2019.03.065. Epub 2019 Aug 30.

    PMID: 31477420RESULT

  • Akbas SH, Ozdem S, Caglar S, Tuncer M, Gurkan A, Yucetin L, Senol Y, Demirbas A, Gultekin M, Ersoy FF, Akaydin M. Effects of some hematological parameters on whole blood tacrolimus concentration measured by two immunoassay-based analytical methods. Clin Biochem. 2005 Jun;38(6):552-7. doi: 10.1016/j.clinbiochem.2005.02.011.

    PMID: 15885236RESULT

  • Krischock LA, van Stralen KJ, Verrina E, Tizard EJ, Bonthuis M, Reusz G, Hussain FK, Jankauskiene A, Novljan G, Spasojevic-Dimitrijeva B, Podracka L, Zaller V, Jager KJ, Schaefer F; ESPN/ERA-EDTA Registry. Anemia in children following renal transplantation-results from the ESPN/ERA-EDTA Registry. Pediatr Nephrol. 2016 Feb;31(2):325-33. doi: 10.1007/s00467-015-3201-8. Epub 2015 Sep 18.

    PMID: 26385862RESULT

  • Chinnakotla S, Verghese P, Chavers B, Rheault MN, Kirchner V, Dunn T, Kashtan C, Nevins T, Mauer M, Pruett T; MNUM Pediatric Transplant Program. Outcomes and Risk Factors for Graft Loss: Lessons Learned from 1,056 Pediatric Kidney Transplants at the University of Minnesota. J Am Coll Surg. 2017 Apr;224(4):473-486. doi: 10.1016/j.jamcollsurg.2016.12.027. Epub 2017 Feb 27.

    PMID: 28254584RESULT

  • Schijvens AM, van Hesteren FHS, Cornelissen EAM, Bootsma-Robroeks CMHHT, Bruggemann RJM, Burger DM, de Wildt SN, Schreuder MF, Ter Heine R. The potential impact of hematocrit correction on evaluation of tacrolimus target exposure in pediatric kidney transplant patients. Pediatr Nephrol. 2019 Mar;34(3):507-515. doi: 10.1007/s00467-018-4117-x. Epub 2018 Oct 30.

    PMID: 30374607RESULT

  • Limsrichamrern S, Chanapul C, Mahawithitwong P, Sirivatanauksorn Y, Kositamongkol P, Asavakarn S, Tovikkai C, Dumronggittigule W. Correlation of Hematocrit and Tacrolimus Level in Liver Transplant Recipients. Transplant Proc. 2016 May;48(4):1176-8. doi: 10.1016/j.transproceed.2015.12.096.

    PMID: 27320581RESULT

MeSH Terms

Interventions

TacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Central Study Contacts

Aya Khalifa, master degree

CONTACT

00201016228446dr.ayaahmedkhlifa@gmail.com

Doaa Salah, MD

CONTACT

002001205551924doaamsalah2010@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 3, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2020

Study Completion

October 1, 2021

Last Updated

March 3, 2020

Record last verified: 2020-02