Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation (SHPT-RT)

Skane University Hospital

Status: Completed

Conditions: Disorder Related to Renal Transplantation; Secondary Hyperparathyroidism

Study type: Observational

Funder types: Other

Identifiers

NCT01741064

SHPTTX-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 257 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Between 18-85 years at date of transplantation
• Signed informed consent or deceased at time of data collection

Exclusion Criteria:

Trial design

257 participants in 3 patient groups

PTH below target iPTH in CKD

Description:

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

Description:

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

Description:

iPTH at one year post transplantation above target range of iPTH by stage of CKD (KDOQI-guidelines).