Renal TransplantNCT01728012
Long-term Cardiovascular Risk Following Successful Renal Transplantation
An observational study of Renal Transplant, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2012to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients registered in the Norwegian Renal Registry with transplan more than 10 years ago.
Who may be able to join
- Registered in the Norwegian Renal Registry
- Documented elevated iPTH at Tx and 10 weeks post-tx
- Well functioning transplant 10 years following tx
- Signed informed consent
Who cannot join
- Lack of ability to comply with the protocol
- Refused written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Cardiovascular Risk Factors in Patients More Than 10 Years Following Successful Renal Transplant.
Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.
- Conditions
- Renal Transplant
- Keywords
- Successful transplantation, Long-term observation
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 |
|---|---|---|
| eGFR >=60ml/min/1.73m2 | Patients with an estimated glomerular filtration rate of >=60 ml/min/1.73m2. | |
| eGFR 45-60ml/min/1.73m2 | Patients with estimated glomerular filtration rate >=45 ml/min/1.73m2 and <60ml/min/1.73m2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast growth factor 23 (FGF23)
To evaluate the long-term effect of a successful renal transplant on this biomarker.
Measured: More than 10 years after successful renal transplantation
Secondary outcomes (3)
Intact parathyroid hormone (iPTH)
To evaluate the long-term effect of a successful renal transplant on this biomarker.
Measured: More than 10 years after successful renal transplantation
Klotho
To evaluate the long-term effect of a successful renal transplant on this biomarker.
Measured: More than 10 years after successful renal transplantation
Neutrophil gelatinase-associated lipocalin (NGAL)
To evaluate the long-term effect of a successful renal transplant on this biomarker.
Measured: More than 10 years after successful renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Inger Hjørdis Bleskestad, MD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728012
- Sponsor's protocol ID
- REK2010/2926
- Status last verified
- Aug 2014
- First submitted
- 8 Nov 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Cardiovascular Risk Factors in Patients More Than 10 Years Following Successful Renal Transplant.
- ClinicalTrials.gov ID
- NCT01728012
- Acronym / sponsor ID
- REK2010/2926
- Conditions
- Renal Transplant
- Keywords
- Successful transplantation, Long-term observation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Nov 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.
Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eGFR >=60ml/min/1.73m2 | – | –Patients with an estimated glomerular filtration rate of >=60 ml/min/1.73m2. |
| eGFR 45-60ml/min/1.73m2 | – | –Patients with estimated glomerular filtration rate >=45 ml/min/1.73m2 and <60ml/min/1.73m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered in the Norwegian Renal Registry with transplan more than 10 years ago.
Key inclusion criteria (4 listed)
- Registered in the Norwegian Renal Registry
- Documented elevated iPTH at Tx and 10 weeks post-tx
- Well functioning transplant 10 years following tx
- Signed informed consent
Key exclusion criteria (2 listed)
- Lack of ability to comply with the protocol
- Refused written informed consent
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
Fibroblast growth factor 23 (FGF23)
Time frame: More than 10 years after successful renal transplantation
To evaluate the long-term effect of a successful renal transplant on this biomarker.
3 secondary outcomes
Intact parathyroid hormone (iPTH)
Time frame: More than 10 years after successful renal transplantation
Klotho
Time frame: More than 10 years after successful renal transplantation
Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: More than 10 years after successful renal transplantation
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 15 Aug 2014.
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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.
Inger Hjørdis Bleskestad, MD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant, run by Helse Stavanger HF at 1 site in Norway.
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 4 inclusion and 2 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Fibroblast growth factor 23 (FGF23) (time frame: More than 10 years after successful renal transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2014.