Clinical Trials Directory

Trials / Completed

CompletedNCT01741064

Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

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

Status
Completed
Phase
Study type
Observational
Enrollment
257 (actual)
Sponsor
Skane University Hospital · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Timeline

Start date
2012-02-01
Primary completion
2012-10-01
Completion
2012-10-01
First posted
2012-12-04
Last updated
2012-12-04

Source: ClinicalTrials.gov record NCT01741064. Inclusion in this directory is not an endorsement.