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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369612
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
Karsten Midtvedt
Information provided by (Responsible Party):
Anders Åsberg, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Failure and Rejection Procedure: Standard follow-up Procedure: Home-based monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Success rate [ Time Frame: 1-8 weeks post-transplant ]
    Complete follow-up without acute rejection and no need for extra visit of any cause


Secondary Outcome Measures :
  1. Extra visits to Control immunosuppressive drug levels [ Time Frame: 1-8 weeks post-transplant ]
    Number of extra visits in order to monitoring appropriate drug Levels of immunosuppressive drugs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369612


Contacts
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Contact: Karsten Midtvedt, MD, PhD 0047-23071894 kmidtved@ous-hf.no
Contact: Anders Åsberg, PhD 0047-23071937 aaasbe@ous-hf.no

Locations
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Norway
Oslo Univeristy Hospital - Rikshospitralet Recruiting
Oslo, Norway, 0424
Contact: Karsten Midtvedt, MD, PhD    0047 23 07 1894    kmidtved@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Karsten Midtvedt
Investigators
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Principal Investigator: Karsten Midtvedt, MD, PhD Oslo University Hospital
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Responsible Party: Anders Åsberg, Head of Laboratory, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04369612    
Other Study ID Numbers: 134787
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not allowed without specific ethical committee approval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anders Åsberg, Oslo University Hospital:
capillary sample, finger-prick, home-based monitoring