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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

Tracking Information
First Submitted Date November 30, 2012
First Posted Date December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date February 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2012)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 3, 2012)
  • Loss of Graft Function [ Time Frame: From date of transplantation to event up to 72 months ]
    Start in Active Uremic Treatment (dialysis, renal transplantation)
  • Overall Mortality [ Time Frame: Fram date of transplantation to event up to 72 months ]
    Mortality
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 3, 2012)
First Fracture [ Time Frame: From date of transplantation to event up to 72 months ]
Fracture verified by x-ray
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Secondary Hyperparathyroidism
  • Disorder Related to Renal Transplantation
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 3, 2012)
257
Original Actual Enrollment Same as current
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01741064
Other Study ID Numbers SHPTTX-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gunnar Sterner, Skane University Hospital
Study Sponsor Skane University Hospital
Collaborators 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
PRS Account Skane University Hospital
Verification Date November 2012