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

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ClinicalTrials.gov Identifier: NCT01741064
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Gunnar Sterner, Skane 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.

Condition or disease
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.

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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 : February 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. First Vascular Event [ Time Frame: From date of transplantation to event up to 72 months ]
    Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)


Secondary Outcome Measures :
  1. Loss of Graft Function [ Time Frame: From date of transplantation to event up to 72 months ]
    Start in Active Uremic Treatment (dialysis, renal transplantation)

  2. Overall Mortality [ Time Frame: Fram date of transplantation to event up to 72 months ]
    Mortality


Other Outcome Measures:
  1. First Fracture [ Time Frame: From date of transplantation to event up to 72 months ]
    Fracture verified by x-ray



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741064


Sponsors and Collaborators
Skane University Hospital
Karolinska University Hospital
Investigators
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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
Publications:
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Responsible Party: Gunnar Sterner, MD, Ass. Prof, Skane University Hospital
ClinicalTrials.gov Identifier: NCT01741064    
Other Study ID Numbers: SHPTTX-002
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Keywords provided by Gunnar Sterner, Skane University Hospital:
Secondary Hyperparathyroidism
Renal Transplantation
Myocardial Infarction
Fracture
Graft Failure
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases