Clinical trial NCT01741064: Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation
Official title: Secondary Hyperparathyroidism Related Vascular and Bone Morbidity After Renal Transplantation - a 6 Year Follow up Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hyperparathyroidism
Disorder Related to Renal Transplantation
Keywords: Secondary Hyperparathyroidism
Renal Transplantation
Myocardial Infarction
Fracture
Graft Failure
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2012-12-04
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent renal transplantation surgery between January 1:st 2003 to December 31:st 2005 at Skane University Hospital or Karolinska University Hospital.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: First Vascular Event
timeFrame: From date of transplantation to event up to 72 months
Secondary outcomes:
measure: Loss of Graft Function
timeFrame: From date of transplantation to event up to 72 months
measure: Overall Mortality
timeFrame: Fram date of transplantation to event up to 72 months
Other outcomes:
measure: First Fracture
timeFrame: From date of transplantation to event up to 72 months
Locations:
Study officials:
affiliation: Dept of Nephrology and Transplantation Skane University Hospital Malmo
name: Gunnar Sterner, MD A/Prof
role: STUDY_DIRECTOR
affiliation: ´Dept of nephrology, Karolinska University Hospital Huddinge, Stockholm
name: Astrid Seeberger, PhD, A/Prof
role: STUDY_CHAIR
affiliation: Dept of Nephrology and Transplantation Skane University Hosptial Malmö
name: Elin Isaksson, MD
role: STUDY_CHAIR
References:
citation: Isaksson E, Sterner G. Early development of secondary hyperparathyroidism following renal transplantation. Nephron Clin Pract. 2012;121(1-2):c68-72. doi: 10.1159/000342811. Epub 2012 Oct 27.
citation: Kanaan N, Claes K, Devogelaer JP, Vanderschueren D, Depresseux G, Goffin E, Evenepoel P. Fibroblast growth factor-23 and parathyroid hormone are associated with post-transplant bone mineral density loss. Clin J Am Soc Nephrol. 2010 Oct;5(10):1887-92. doi: 10.2215/CJN.00950110. Epub 2010 Jul 15.
citation: Goldsmith D, Kothawala P, Chalian A, Bernal M, Robbins S, Covic A. Systematic review of the evidence underlying the association between mineral metabolism disturbances and risk of fracture and need for parathyroidectomy in CKD. Am J Kidney Dis. 2009 Jun;53(6):1002-13. doi: 10.1053/j.ajkd.2009.02.010.
citation: Evenepoel P, Meijers BK, de Jonge H, Naesens M, Bammens B, Claes K, Kuypers D, Vanrenterghem Y. Recovery of hyperphosphatoninism and renal phosphorus wasting one year after successful renal transplantation. Clin J Am Soc Nephrol. 2008 Nov;3(6):1829-36. doi: 10.2215/CJN.01310308. Epub 2008 Oct 15.