Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04369612
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2020-04-28
Brief Title:
Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Home Based Monitoring of Kidney Transplants Utilizing Capillary Microsamples
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBM-KTx
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 11 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
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 ie first kidney only transplants no donors specific antibodies DSA panel reactive antibodies PRA ABO blood type compatible transplant will be randomized 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None