Predictors of Rejection in Pediatric Kidney Transplantation

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04292418
• Collaborator: (none)
• Enrollment: 70
• Anticipated Duration (Months): 17

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rejection Acute Renal	Drug: Tacrolimus capsule , mycophenolic acid

Detailed 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) .

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Predictors of Rejection in Pediatric Kidney Transplantation
• Anticipated Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; 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 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; 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

Outcome Measures

Primary Outcome Measures

1. predictors of rejection [2 year]

   detect the potentially predictors of rejection in pediatric kidney transplant recipient

Secondary Outcome Measures

1. measure corrected tacrolimus level and mycophenolic acid [2 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aya Khalifa, Principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04292418
• Other Study ID Numbers: PKTX
• First Posted: Mar 3, 2020
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mycophenolic Acid; Tacrolimus

Study Results

No Results Posted as of Mar 3, 2020