Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Kidney Transplant Failure and Rejection Clinical Trial

— HBM-KTx  

Official title:

Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369612
• Other study ID #: 134787
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Karsten Midtvedt, MD, PhD
• Phone: 0047-23071894
• Email: kmidtved[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Failure and Rejection

Intervention

Procedure:
• Standard follow-up
Standard post-transplant follow-up
• Home-based monitoring
Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician

Locations

Country	Name	City	State
Norway	Oslo Univeristy Hospital - Rikshospitralet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Complete follow-up without acute rejection and no need for extra visit of any cause	1-8 weeks post-transplant
Secondary	Extra visits to Control immunosuppressive drug levels	Number of extra visits in order to monitoring appropriate drug Levels of immunosuppressive drugs	1-8 weeks post-transplant