SHPT-RT: Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

Sponsor

Skane University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01741064

Collaborator

Karolinska University Hospital (Other)

257

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism Disorder Related to Renal Transplantation

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.

Study Design

Study Type:

Observational

Actual Enrollment :

257 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
PTH below target iPTH in CKD 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 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 iPTH at one year post transplantation above target range of iPTH by stage of CKD (KDOQI-guidelines).

Outcome Measures

Primary Outcome Measures

First Vascular Event [From date of transplantation to event up to 72 months]
Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)

Secondary Outcome Measures

Loss of Graft Function [From date of transplantation to event up to 72 months]
Start in Active Uremic Treatment (dialysis, renal transplantation)
Overall Mortality [Fram date of transplantation to event up to 72 months]
Mortality

Other Outcome Measures

First Fracture [From date of transplantation to event up to 72 months]
Fracture verified by x-ray

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Skane University Hospital
Karolinska University Hospital

Investigators

Study Director: Gunnar Sterner, MD A/Prof, Dept of Nephrology and Transplantation Skane University Hospital Malmo
Study Chair: Astrid Seeberger, PhD, A/Prof, ´Dept of nephrology, Karolinska University Hospital Huddinge, Stockholm
Study Chair: Elin Isaksson, MD, Dept of Nephrology and Transplantation Skane University Hosptial Malmö