Clinical trial NCT04369612: Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
Official title: Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant Failure and Rejection
Keywords: capillary sample, finger-prick, home-based monitoring
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two Groups, randomized 1:1, to a) Standard of care and b) home-based monitoring. Followed between 1-2 to 7-8 weeks after transplantation
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate
timeFrame: 1-8 weeks post-transplant
Secondary outcomes:
measure: Extra visits to Control immunosuppressive drug levels
timeFrame: 1-8 weeks post-transplant
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Univeristy Hospital - Rikshospitralet
Study officials:
affiliation: Oslo University Hospital
name: Karsten Midtvedt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: