Predictors of Rejection in Pediatric Kidney Transplantation

Rejection Acute Renal Clinical Trial

Official title:

Predictors of Rejection in Pediatric Kidney Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04292418
• Other study ID #: PKTX
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Aya Khalifa, master degree
• Phone: 00201016228446
• Email: dr.ayaahmedkhlifa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF). Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

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

2. patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids

3. recipients with biopsy proven acute rejection in the studied group.

Exclusion Criteria:

1. patients on cyclosporine

2. patients with active infection and dehydration

3. Patients who received multiorgan transplantation Non cooperative patient will be excluded

Related Conditions & MeSH terms

• Rejection Acute Renal

Intervention

Drug:
• Tacrolimus capsule , mycophenolic acid
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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 B — View Citation

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. — View Citation

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 Unive — View Citation

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 transplantatio — View Citation

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: 1 — View Citation

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. — View Citation

Schijvens AM, van Hesteren FHS, Cornelissen EAM, Bootsma-Robroeks CMHHT, Brüggemann 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 trans — View Citation

Tamain M, Sayegh J, Lionet A, Grimbert P, Philipponnet C, Hazzan M, Augusto JF, Büchler 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 re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictors of rejection	detect the potentially predictors of rejection in pediatric kidney transplant recipient	2 year
Secondary	measure corrected tacrolimus level and mycophenolic acid	detect the role of corrected tacrolimus level in dose adjustment for better control of immunosuppressive therapy detect the role of neutrophil to lymphocytic ratio in prediction of kidney rejection Role of mycophenolic acid monitoring in prevention of rejection	2 year