Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples (HBM-KTx)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant Failure and Rejection
• Intervention / Treatment: Procedure: Standard follow-up; Procedure: Home-based monitoring

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karsten Midtvedt, MD, PhD; Phone Number: 0047-23071894; Email: kmidtved@ous-hf.no
• Study Contact Backup: Name: Anders Åsberg, PhD; Phone Number: 0047-23071937; Email: aaasbe@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo Univeristy Hospital - Rikshospitralet
    • Contact: Karsten Midtvedt, MD, PhD; Phone Number: 0047 23 07 1894; Email: kmidtved@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks	Procedure: Standard follow-up; Standard post-transplant follow-up
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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Karsten Midtvedt, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: capillary sample, finger-prick, home-based monitoring
• Other Study ID Numbers: 134787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed without specific ethical committee approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No