Focal Segmental GlomerulosclerosisNCT04369183
Rituximab for Refractory or Relapsed Focal Segmental Glomerulosclerosis or Minimal Change Disease
An observational study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis, Minimal Change Disease
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Oct 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
Who may be able to join
- Having biopsy-proven focal segmental glomerulosclerosis or minimal change disease.
- Showing resistance to or relapsing after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
- Having a history of rituximab use (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after aforementioned agents.
Who cannot join
- Not providing or withdrawing consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives have been seen as a second line agent. However, treatment options in refractory or relapsed cases are still under debate. Recently, rituximab has become an alternative in those patients. Therefore, a study based on registry data was conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a relapsed or refractory primary FSGS or MCD.
- Keywords
- focal segmental glomerulosclerosis, minimal change disease, rituximab
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid
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 |
|---|---|---|
| Study Group | Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission
Proteinuria <0.5 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
Measured: 12 months
Partial Remission
Proteinuria <3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Sep 2019
- Primary completion31 Aug 2020
- Study completion31 Oct 2020
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 Focal Segmental GlomerulosclerosisStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safak Mirioglu, Istanbul University
- Investigators
- Halil Yazici, MD, Study chair, Department of Internal Medicine, Istanbul Faculty of MedicineSafak Mirioglu, MD, Principal investigator, Department of Internal Medicine, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369183
- Sponsor's protocol ID
- 2019/977
- Status last verified
- Nov 2020
- First submitted
- 25 Apr 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, Massella L, Marasa M, Chianca A, Rubis N, Ene-Iordache B, Rudnicki M, Pollastro RM, Capasso G, Pisani A, Pennesi M, Emma F, Remuzzi G; Rituximab in Nephrotic Syndrome of Steroid-Dependent or Frequently Relapsing Minimal Change Disease Or Focal Segmental Glomerulosclerosis (NEMO) Study Group. Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome. J Am Soc Nephrol. 2014 Apr;25(4):850-63. doi: 10.1681/ASN.2013030251. Epub 2014 Jan 30.
PubMed 24480824
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
- ClinicalTrials.gov ID
- NCT04369183
- Acronym / sponsor ID
- 2019/977
- Keywords
- focal segmental glomerulosclerosis, minimal change disease, rituximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 30 Apr 2020 (actual)
- 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.
Various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives have been seen as a second line agent. However, treatment options in refractory or relapsed cases are still under debate. Recently, rituximab has become an alternative in those patients. Therefore, a study based on registry data was conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a relapsed or refractory primary FSGS or MCD.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
Key inclusion criteria (3 listed)
- Having biopsy-proven focal segmental glomerulosclerosis or minimal change disease.
- Showing resistance to or relapsing after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
- Having a history of rituximab use (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after aforementioned agents.
Key exclusion criteria (1 listed)
- Not providing or withdrawing 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
Complete Remission
Time frame: 12 months
Proteinuria <0.5 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
Partial Remission
Time frame: 12 months
Proteinuria <3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.
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 1 Dec 2020.
- Background: PubMed 24480824Ruggenenti P, Ruggiero B, Cravedi P, Vivarelli M, Massella L, Marasa M, Chianca A, Rubis N, Ene-Iordache B, Rudnicki M, Pollastro RM, Capasso G, Pisani A, Pennesi M, Emma F, Remuzzi G; Rituximab in Nephrotic Syndrome of Steroid-Dependent or Frequently Relapsing Minimal Change Disease Or Focal Segmental Glomerulosclerosis (NEMO) Study Group. Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome. J Am Soc Nephrol. 2014 Apr;25(4):850-63. doi: 10.1681/ASN.2013030251. Epub 2014 Jan 30.
- Individual participant dataSharing planned: No
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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.
Halil Yazici, MD study chair
Department of Internal Medicine, Istanbul Faculty of Medicine
Safak Mirioglu, MD principal investigator
Department of Internal Medicine, Istanbul Faculty of Medicine
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 Focal Segmental Glomerulosclerosis and Minimal Change Disease, run by Istanbul University at 1 site 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 1 Dec 2020. 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 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?
Complete Remission (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04369183, 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 1 Dec 2020.