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

December 3, 2012 updated by: Gunnar Sterner, Skane University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From date of transplantation to event up to 72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of Graft Function
Time Frame: From date of transplantation to event up to 72 months
Start in Active Uremic Treatment (dialysis, renal transplantation)
From date of transplantation to event up to 72 months
Overall Mortality
Time Frame: Fram date of transplantation to event up to 72 months
Mortality
Fram date of transplantation to event up to 72 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Fracture
Time Frame: From date of transplantation to event up to 72 months
Fracture verified by x-ray
From date of transplantation to event up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHPTTX-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Secondary Hyperparathyroidism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe