GlomerulonephritisNCT02700516
Recurrent Glomerulonephritis After Renal Transplantation
An observational study of Glomerulonephritis, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. The exact prevalence of either recurrent or de novo GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving GN underdiagnosed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerulonephritis
- How many people
- 360 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Mar 2015to Apr 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
- Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have biopsy-proven recurrent primary glomerulonephritis (Recurrent GN group)
- Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have no signs of recurrence (Non-recurrent GN group)
- Patients who underwent a renal transplantation because of an end-stage renal disease linked to an etiology other than primary glomerulonephritis (Non-GN group)
Who cannot join
- Patients who are unwilling or unable to consent
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
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
About this study
Official title: Recurrent Primary Glomerulonephritis After Renal Transplantation: Effects on Renal Allografts and Transplant Recipients
Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. The exact prevalence of either recurrent or de novo GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN on the prevalence, risk factors, clinicopathological features, and outcome of renal transplant recipients.
Read the detailed description
Glomerulonephritis is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. Even though recurrent or de novo posttransplant primary GN is the third most frequent cause of renal allograft loss after renal transplantation, different recurrence rates have been reported in different patient series worldwide. With the implementation of diverse and improved immunosuppressive treatment regimens and prolongation of graft survival, renal allograft loss caused by recurrent or de novo GN will be more important than ever. Data obtained from comparing patients who have recurrent primary GN against patients with non-recurrent GN and renal transplant recipients with non-GN etiology shall bring new approaches to the daily practice of managing patients with GN and renal failure, assessing them as transplant candidates and applying new therapies.
- Conditions
- Glomerulonephritis
- Medical subject headings
- Glomerulonephritis
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 GN | Renal transplant recipients with biopsy-confirmed recurrent primary glomerulonephritis. | |
| Non-recurrent GN | Renal transplant recipients with non-recurrent primary glomerulonephritis. | |
| Non-GN | Renal transplant recipients with etiologies other than primary glomerulonephritis. |
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 posted7 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionApr 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 GlomerulonephritisStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 360 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
- NCT02700516
- Sponsor's protocol ID
- 32364/200
- Status last verified
- Apr 2016
- First submitted
- 25 Feb 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Briganti EM, Russ GR, McNeil JJ, Atkins RC, Chadban SJ. Risk of renal allograft loss from recurrent glomerulonephritis. N Engl J Med. 2002 Jul 11;347(2):103-9. doi: 10.1056/NEJMoa013036.
PubMed 12110738
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Primary Glomerulonephritis After Renal Transplantation: Effects on Renal Allografts and Transplant Recipients
- ClinicalTrials.gov ID
- NCT02700516
- Acronym / sponsor ID
- 32364/200
- Conditions
- Glomerulonephritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 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.
Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. The exact prevalence of either recurrent or de novo GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN on the prevalence, risk factors, clinicopathological features, and outcome of renal transplant recipients.
Detailed description
Glomerulonephritis is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. Even though recurrent or de novo posttransplant primary GN is the third most frequent cause of renal allograft loss after renal transplantation, different recurrence rates have been reported in different patient series worldwide. With the implementation of diverse and improved immunosuppressive treatment regimens and prolongation of graft survival, renal allograft loss caused by recurrent or de novo GN will be more important than ever. Data obtained from comparing patients who have recurrent primary GN against patients with non-recurrent GN and renal transplant recipients with non-GN etiology shall bring new approaches to the daily practice of managing patients with GN and renal failure, assessing them as transplant candidates and applying new therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recurrent GN | – | –Renal transplant recipients with biopsy-confirmed recurrent primary glomerulonephritis. |
| Non-recurrent GN | – | –Renal transplant recipients with non-recurrent primary glomerulonephritis. |
| Non-GN | – | –Renal transplant recipients with etiologies other than primary glomerulonephritis. |
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 (3 listed)
- Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have biopsy-proven recurrent primary glomerulonephritis (Recurrent GN group)
- Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have no signs of recurrence (Non-recurrent GN group)
- Patients who underwent a renal transplantation because of an end-stage renal disease linked to an etiology other than primary glomerulonephritis (Non-GN group)
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 5 Apr 2016.
- Background: PubMed 12110738Briganti EM, Russ GR, McNeil JJ, Atkins RC, Chadban SJ. Risk of renal allograft loss from recurrent glomerulonephritis. N Engl J Med. 2002 Jul 11;347(2):103-9. doi: 10.1056/NEJMoa013036.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerulonephritis, run by Istanbul University at 2 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 3 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 NCT02700516, 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 5 Apr 2016.