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Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

NCT ID: NCT01741064

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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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

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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

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Secondary Hyperparathyroidism Disorder Related to Renal Transplantation

Keywords

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Secondary Hyperparathyroidism Renal Transplantation Myocardial Infarction Fracture Graft Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PTH below target iPTH in CKD

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

No interventions assigned to this group

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Sterner

MD, Ass. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Sterner, MD A/Prof

Role: STUDY_DIRECTOR

Dept of Nephrology and Transplantation Skane University Hospital Malmo

Astrid Seeberger, PhD, A/Prof

Role: STUDY_CHAIR

´Dept of nephrology, Karolinska University Hospital Huddinge, Stockholm

Elin Isaksson, MD

Role: STUDY_CHAIR

Dept of Nephrology and Transplantation Skane University Hosptial Malmö

References

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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.

Reference Type BACKGROUND
PMID: 23107897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20634326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19463763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18922992 (View on PubMed)

Other Identifiers

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SHPTTX-002

Identifier Type: -

Identifier Source: org_study_id