Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

Secondary Hyperparathyroidism Clinical Trial

— SHPT-RT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741064
• Other study ID #: SHPTTX-002
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: December 3, 2012
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Skåne University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Between 18-85 years at date of transplantation

• Signed informed consent or deceased at time of data collection

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Skåne University Hospital	Karolinska University Hospital

References & Publications (4)

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. — View 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. Review. — View 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. Erratum in: Nephron Clin Pract. 2012;121(3-4):c111. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	First Fracture	Fracture verified by x-ray	From date of transplantation to event up to 72 months	No
Primary	First Vascular Event	Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)	From date of transplantation to event up to 72 months	No
Secondary	Loss of Graft Function	Start in Active Uremic Treatment (dialysis, renal transplantation)	From date of transplantation to event up to 72 months	No
Secondary	Overall Mortality	Mortality	Fram date of transplantation to event up to 72 months	No