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Kidney Transplantation and Renal and Myocardial Perfusion (Transkidney)

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ClinicalTrials.gov Identifier: NCT02960802
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Johanna Paivarinta, Turku University Hospital

Brief Summary:

The cardiovascular morbidity and mortality is significantly higher in chronic kidney disease (CKD) patients, especially in dialysis patients, than in normal population. The increased risk of cardiovascular diseases is multifactorial.Endothelial dysfunction is one of the explanations for the poor outcome of kidney patients. The kidney transplantation seems to halt the progression of the cardiovascular morbidity.

Coronary flow reserve (CFR), the capacity of coronary vessels to dilate in response to vasoactive agent, is a marker of the endothelial dysfunction. It is reduced in renal impairment as well as in many preatherosclerotic states and coronary heart disease. The method of choice to evaluate CRF is positron emission tomography (PET). In kidney transplant patients CFR seems to be worse than in healthy controls but better than in dialysis patients. However, the evidence is scarce.

Renal flow reserve (RFR) is smaller than that of heart. RFR probably reflects endothelial function in the same way as CFR does. Declining RFR could perhaps be used to anticipate worsening kidney function especially in kidney transplant patients and be in favour for transplant biopsy.There are no studies of RFR in renal allograft patients.

The objectives of this study are to examine the effect of kidney transplantation on coronary flow reserve (CFR), the change of renal flow reserve (RFR) in kidney transplant patients during the first year after transplantation and assess the correlation between the change of renal blood flow / RFR and kidney biopsy findings in kidney transplant patients.

The first hypothesis of this study is that coronary flow reserve of transplant patients is better than that of dialysis patients but worse than that of healthy controls. The second hypothesis is that renal transplant perfusion reserve is better at one year than at three months after transplantation. The third hypothesis is that pathologic kidney biopsy findings correlate negatively with renal perfusion reserve.


Condition or disease Intervention/treatment Phase
Kidney Transplant Failure Procedure: kidney transplantation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Kidney Transplantation and Renal and Myocardial Perfusion
Study Start Date : January 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: kidney transplant patient
kidney transplantation is intervention
Procedure: kidney transplantation
Other Name: transplant

No Intervention: healthy control
no intervention



Primary Outcome Measures :
  1. renal flow reserve of kidney transplant patients [ Time Frame: one year ]
    renal flow reserve of kidney transplant patients is measured by PET-camera at 3 months and at one year after transplantation, unit is ml/ml (blood/renal tissue)

  2. cardiac flow reserve of kidney transplant patients [ Time Frame: supposed to be 1-3 years depending how quickly patient gets the transplant ]
    cardiac flow reserve is measured by PET-camera during dialysis time and at one year after transplantation, unit is ml/g


Secondary Outcome Measures :
  1. the difference of cardiac flow reserve of kidney transplant patients who have been previously peritoneal dialysis or hemodialysis patients [ Time Frame: supposed to be 1-3 years depending how quickly patient gets the transplant ]
    the cardiac flow reserve is measured by PET during dialysis and at one year after kidney transplantation, unit is ml/g



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • dialysis patients who are on the kidney waiting list

Exclusion Criteria:

  • diabetes, hypertension, coronary artery disease, cerebrovascular disease, universal atherosclerosis

In the retrospective part of the study, inclusion criteria:

  • kidney transplant is 3+/-1years old
  • GFR >30 ml/min Exclusion criteria
  • manifest coronary artery disease, cerebrovascular disease, universal atherosclerosis

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): NCT02960802


Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Johanna Päivärinta, MD Turku University Hospital

Additional Information:
Publications of Results:

Responsible Party: Johanna Paivarinta, MD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02960802     History of Changes
Other Study ID Numbers: T257/2016
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is obtained via imaging (PET). The data includes perfusion values of kidneys and heart. The data will be available in the end of study period, 12/2022.

Keywords provided by Johanna Paivarinta, Turku University Hospital:
kidney transplant
renal blood flow