Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples

NCT04369612 | Recruiting

• 1 other identifier: 134787
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Failure and Rejection

Keywords

capillary sample, finger-prick, home-based monitoring

Outcome Measures

Primary Outcomes (1)

• Success rate

  Complete follow-up without acute rejection and no need for extra visit of any cause

  1-8 weeks post-transplant

Secondary Outcomes (1)

• Extra visits to Control immunosuppressive drug levels

  1-8 weeks post-transplant

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Standard follow-up after kidney transplantation during the first 7-8 post-transplant weeks

Procedure: Standard follow-up

Home-based monitoring

EXPERIMENTAL

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

Interventions

Standard follow-up PROCEDURE

Standard post-transplant follow-up

Standard of care

Home-based monitoring PROCEDURE

Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician

Home-based monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breast feeding female recipients

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo Univeristy Hospital - Rikshospitralet

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Karsten Midtvedt, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karsten Midtvedt, MD, PhD

CONTACT

0047-23071894; kmidtved@ous-hf.no

Anders Åsberg, PhD

CONTACT

0047-23071937; aaasbe@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory

Model Details: 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

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: April 28, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)