Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the long term vascular morbidity and mortality in kidney transplant recipients based on one year post transplant levels of intact parathyroid hormone.

Detailed Description
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Secondary hyperparathyroidism (SHPT) is a well known complication to chronic renal failure. With impaired renal function the phosphate excretion from the kidney is reduced. Together with low levels of 25- and 1,25-vitamin D3 and hypocalcemia this uremic mineral milieu drives the release of parathyroid hormone (PTH) and the development of SHPT. PTH has many functions but acts mainly to release calcium from the skeleton, to enhance calcium uptake from the intestines (by actions on vitamin D) and to lower serum phosphate by inducing phosphaturia. SHPT has been shown to cause vascular morbidity and fractures in the chronic kidney disease (CKD) patient. After successful renal transplantation (RT) the mineral disturbances are mostly recovered and stabilized at one year post RT, but in recent years it has been shown that SHPT persists in the major part of RT-recipients even after long term follow up. This has been associated with high risk of fractures and vascular related morbidity in the post transplant period. It has also been shown that low levels of iPTH in the post-transplant period might be associated with a high risk of fractures. Because of insufficient data on PTH levels and associated morbidity there is no specific recommendations of target PTH levels in the RT-patient. This indicates that there is need for further observational studies to describe the SHPT-associated morbidity in a post transplant cohort based on stabilized levels of post transplant iPTH.

Official Title
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Secondary Hyperparathyroidism Related Vascular and Bone Morbidity After Renal Transplantation - a 6 Year Follow up Retrospective Cohort Study.

Conditions
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Secondary Hyperparathyroidism, Disorder Related to Renal Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18-85 years at date of transplantation Signed informed consent or deceased at time of data collection Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PTH below target iPTH in CKD<br>iPTH at one year post transplantation below target range of iPTH by stage of CKD (KDOQI-guidelines). | |
| iPTH within target range of iPTH in CKD<br>iPTH at one year post transplantation within target range of iPTH by stage of CKD (KDOQI-guidelines). | |
| iPTH above target range of iPTH in CKD<br>iPTH at one year post transplantation above target range of iPTH by stage of CKD (KDOQI-guidelines). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Vascular Event | Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion) | From date of transplantation to event up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of Graft Function | Start in Active Uremic Treatment (dialysis, renal transplantation) | From date of transplantation to event up to 72 months | 
| Overall Mortality | Mortality | Fram date of transplantation to event up to 72 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Hyperparathyroidism, Renal Transplantation, Myocardial Infarction, Fracture, Graft Failure