Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Oslo Univeristy Hospital - Rikshospitralet
RECRUITING
Oslo
Contact Information
Primary
Karsten Midtvedt, MD, PhD
kmidtved@ous-hf.no
0047-23071894
Backup
Anders Åsberg, PhD
aaasbe@ous-hf.no
0047-23071937
Time Frame
Start Date: 2020-04-28
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Standard of care
Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov

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