Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Not Applicable

Recruiting

• Conditions: Kidney Transplant Failure and Rejection
• Interventions: Procedure: Standard follow-up; Procedure: Home-based monitoring

• Registration Number: NCT04369612
• Lead Sponsor: Oslo University Hospital

Brief Summary

Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves, send it to the laboratory for analysis and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure.

Detailed Description

Renal transplant recipients are followed as out patients at the transplant center for about 8 weeks after surgery. Between 1-2 weeks after surgery, 50 standard immunological patients (i.e. first, kidney (only) transplants, no donors specific antibodies (DSA), panel reactive antibodies (PRA), ABO blood type compatible transplant) will be randomized (1:1) to either follow standard of care (SOC) or having every second poli clinical visit without entering the hospital HBM; Home Based Monitoring). They are to take a capillary finger-prick blood sample themselves and send it to the laboratory for analysis (creatinine, hemoglobin, tacrolimus and mycophenolate) and then they will get a telecom follow-up that day from their transplant physician. Outcome is no difference with regards to being able to follow the randomized follow-up procedure without having acute rejection episodes and no need for extra ou-patients visits for any reason. End of study is week 7-8 after transplantation.

Study Timeline

• Study Start: 2020-04-28
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Kidney only transplant
• Immunosuppressive therapy With at least one of; tacrolimus, cyclosporine, everolimus, sirolimus, mycophenolate
• Standard immunological risk; no DSA, no PRA, not ABO-incompatible transplant
• Age above 18 years
• Followed at Oslo University Hospital-Rikshospitalet transplant center
• Written informed consent

Exclusion Criteria

• Pregnant or breast feeding female recipients
• Ongoing acute rejection episodes at time of inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard follow-up	Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks
Home-based monitoring	Home-based monitoring	Every second visit will be performed without patients actually visiting the hospital. They take a capillary blood sample themselves, send it to the lab and get a telecom follow-up by treating physician the same day.

Primary Outcome Measures

Name	Time	Method
Success rate	1-8 weeks post-transplant	Complete follow-up without acute rejection and no need for extra visit of any cause

Secondary Outcome Measures

Name	Time	Method
Extra visits to Control immunosuppressive drug levels	1-8 weeks post-transplant	Number of extra visits in order to monitoring appropriate drug Levels of immunosuppressive drugs

Trial Locations

Locations (1)

Oslo Univeristy Hospital - Rikshospitralet; 🇳🇴 Oslo, Norway