Secondary HyperparathyroidismSHPT-RTNCT01741064
Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation
An observational study of Secondary Hyperparathyroidism and Disorder Related to Renal Transplantation, run by Skane University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Secondary Hyperparathyroidism, Disorder Related to Renal Transplantation
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Between 18-85 years at date of transplantation
- Signed informed consent or deceased at time of data collection
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Keywords
- Secondary Hyperparathyroidism, Renal Transplantation, Myocardial Infarction, Fracture, Graft Failure
- Medical subject headings
- Hyperparathyroidism, Secondary, Myocardial Infarction, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
First Vascular Event
Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)
Measured: From date of transplantation to event up to 72 months
Secondary outcomes (2)
Loss of Graft Function
Start in Active Uremic Treatment (dialysis, renal transplantation)
Measured: From date of transplantation to event up to 72 months
Overall Mortality
Mortality
Measured: Fram date of transplantation to event up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Gunnar Sterner, Skane University Hospital
- Investigators
- Gunnar Sterner, MD A/Prof, Study director, Dept of Nephrology and Transplantation Skane University Hospital MalmoAstrid Seeberger, PhD, A/Prof, Study chair, ´Dept of nephrology, Karolinska University Hospital Huddinge, StockholmElin Isaksson, MD, Study chair, Dept of Nephrology and Transplantation Skane University Hosptial Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741064
- Sponsor's protocol ID
- SHPTTX-002
- Acronym
- SHPT-RT
- Status last verified
- Nov 2012
- First submitted
- 30 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23107897Kanaan 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.
PubMed 20634326Goldsmith 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.
PubMed 19463763Evenepoel 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.
PubMed 18922992
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Hyperparathyroidism Related Vascular and Bone Morbidity After Renal Transplantation - a 6 Year Follow up Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT01741064
- Acronym / sponsor ID
- SHPT-RT / SHPTTX-002
- Keywords
- Secondary Hyperparathyroidism, Renal Transplantation, Myocardial Infarction, Fracture, Graft Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Between 18-85 years at date of transplantation
- Signed informed consent or deceased at time of data collection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Loss of Graft Function
Time frame: From date of transplantation to event up to 72 months
Overall Mortality
Time frame: Fram date of transplantation to event up to 72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Background: PubMed 23107897Isaksson 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.
- Background: PubMed 20634326Kanaan 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.
- Background: PubMed 19463763Goldsmith 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.
- Background: PubMed 18922992Evenepoel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Sterner, MD A/Prof study director
Dept of Nephrology and Transplantation Skane University Hospital Malmo
Astrid Seeberger, PhD, A/Prof study chair
´Dept of nephrology, Karolinska University Hospital Huddinge, Stockholm
Elin Isaksson, MD study chair
Dept of Nephrology and Transplantation Skane University Hosptial Malmö
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hyperparathyroidism and Disorder Related to Renal Transplantation, run by Skane University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Vascular Event (time frame: From date of transplantation to event up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741064, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.