AA AmyloidosisNCT02704065
Recurrent AA Amyloidosis After Renal Transplantation
An observational study of AA Amyloidosis, run by Istanbul University at 4 sites in Turkey (Türkiye).
Trial summary
End-stage renal disease related to AA amyloidosis is well characterized but there is limited data concerning patient and graft outcomes after renal transplantation. The aim of this study is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as well as the effects of these factors on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AA Amyloidosis
- How many people
- 54 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Feb 2016to Dec 2016
- 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: Renal transplant recipients
Who may be able to join
- Renal transplantation recipients whose primary renal disease is AA amyloidosis; patients with allograft biopsy-confirmed AA amyloidosis (for study group) and patients with no clinical or laboratory signs of recurrence in the renal allograft (for control group 1)
- Renal transplantation recipients whose primary diseases are other than AA amyloidosis (for control group 2)
Who cannot join
- Patients who are unwilling or unable to consent
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Division of Nephrology, Department of Internal Medicine, Uludag University Faculty of Medicine
Bursa
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Istanbul, 34093
Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine
Istanbul
Division of Nephrology, Sisli Hamidiye Etfal Training and Education Hospital
Istanbul
About this study
Official title: Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival
End-stage renal disease related to AA amyloidosis is well characterized but there is limited data concerning patient and graft outcomes after renal transplantation. The aim of this study is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as well as the effects of these factors on the ultimate outcome of renal allografts.
Read the detailed description
AA amyloidosis is a rare but serious complication of several chronic inflammatory diseases including recurrent hereditary periodic fever syndromes. Although end-stage renal disease related to AA amyloidosis is well characterized, there is limited data concerning patient and graft outcomes after renal transplantation, with most of the findings reported from small series. Recurrence of amyloidosis in the renal allograft might be underdiagnosed, assessing graft and patient outcomes in larger study groups will bring better understanding and new strategies in daily practice.
- Conditions
- AA Amyloidosis
- Keywords
- amyloidosis, renal transplantation
- Medical subject headings
- AA amyloidosis, Amyloidosis
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 |
|---|---|---|
| Recurrent AA amyloidosis | Renal transplant recipients with biopsy-confirmed AA amyloidosis in the renal allograft | |
| Control group 1 | Renal transplant recipients whose primary diseases are amyloidosis with no clinical or laboratory signs of recurrence in the renal allograft | |
| Control group 2 | Renal transplant recipients whose primary diseases are other than amyloidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allograft survival
Measured: 1 - 5 years
Secondary outcomes (1)
Allograft rejection
Measured: 1 - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AA AmyloidosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Caliskan, Istanbul University
- Investigators
- Yasar Caliskan, MD, Principal investigator, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704065
- Sponsor's protocol ID
- 32447/199
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kofman T, Grimbert P, Canoui-Poitrine F, Zuber J, Garrigue V, Mousson C, Frimat L, Kamar N, Couvrat G, Bouvier N, Albano L, Le Thuaut A, Pillebout E, Choukroun G, Couzi L, Peltier J, Mariat C, Delahousse M, Buchler M, Le Pogamp P, Bridoux F, Pouteil-Noble C, Lang P, Audard V. Renal transplantation in patients with AA amyloidosis nephropathy: results from a French multicenter study. Am J Transplant. 2011 Nov;11(11):2423-31. doi: 10.1111/j.1600-6143.2011.03620.x. Epub 2011 Jun 30.
PubMed 21714848
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival
- ClinicalTrials.gov ID
- NCT02704065
- Acronym / sponsor ID
- 32447/199
- Conditions
- AA Amyloidosis
- Keywords
- amyloidosis, renal transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Mar 2016 (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.
End-stage renal disease related to AA amyloidosis is well characterized but there is limited data concerning patient and graft outcomes after renal transplantation. The aim of this study is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as well as the effects of these factors on the ultimate outcome of renal allografts.
Detailed description
AA amyloidosis is a rare but serious complication of several chronic inflammatory diseases including recurrent hereditary periodic fever syndromes. Although end-stage renal disease related to AA amyloidosis is well characterized, there is limited data concerning patient and graft outcomes after renal transplantation, with most of the findings reported from small series. Recurrence of amyloidosis in the renal allograft might be underdiagnosed, assessing graft and patient outcomes in larger study groups will bring better understanding and new strategies in daily practice.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recurrent AA amyloidosis | – | –Renal transplant recipients with biopsy-confirmed AA amyloidosis in the renal allograft |
| Control group 1 | – | –Renal transplant recipients whose primary diseases are amyloidosis with no clinical or laboratory signs of recurrence in the renal allograft |
| Control group 2 | – | –Renal transplant recipients whose primary diseases are other than amyloidosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant recipients
Key inclusion criteria (2 listed)
- Renal transplantation recipients whose primary renal disease is AA amyloidosis; patients with allograft biopsy-confirmed AA amyloidosis (for study group) and patients with no clinical or laboratory signs of recurrence in the renal allograft (for control group 1)
- Renal transplantation recipients whose primary diseases are other than AA amyloidosis (for control group 2)
Key exclusion criteria (1 listed)
- Patients who are unwilling or unable to 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
Allograft survival
Time frame: 1 - 5 years
1 secondary outcome
Allograft rejection
Time frame: 1 - 5 years
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 18 Apr 2017.
- Background: PubMed 21714848Kofman T, Grimbert P, Canoui-Poitrine F, Zuber J, Garrigue V, Mousson C, Frimat L, Kamar N, Couvrat G, Bouvier N, Albano L, Le Thuaut A, Pillebout E, Choukroun G, Couzi L, Peltier J, Mariat C, Delahousse M, Buchler M, Le Pogamp P, Bridoux F, Pouteil-Noble C, Lang P, Audard V. Renal transplantation in patients with AA amyloidosis nephropathy: results from a French multicenter study. Am J Transplant. 2011 Nov;11(11):2423-31. doi: 10.1111/j.1600-6143.2011.03620.x. Epub 2011 Jun 30.
- Individual participant dataSharing planned: Undecided
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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.
Yasar Caliskan, MD principal investigator
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AA Amyloidosis, run by Istanbul University at 4 sites in Turkey (Türkiye).
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 1 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). 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?
Allograft survival (time frame: 1 - 5 years). 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 NCT02704065, which also lists 1 linked publication.
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 18 Apr 2017.