Fibrillary GlomerulonephritisPhase 2NCT02197767
Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
A Phase 2 study testing rituximab in people with Fibrillary Glomerulonephritis, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Fibrillary Glomerulonephritis
- What is being tested?
- rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibrillary Glomerulonephritis with diagnostic biopsy performed within the last 2 years
- Proteinuria >1 gram
- Age > 18 years but < 80 years
- Adequately controlled blood pressure (BP<140/90 mmHg in >75% of the readings) for at least 3 months prior to enrollment with the use of (angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin-receptor blockers (ARB), if tolerated.
- Women must be post- menopausal, surgically sterile or practicing a medically approved method of contraception
- Able and willing to give written informed consent and comply with the requirements of the study protocol
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- Adequate renal function as indicated by estimated glomerular filtration rate (GFR) > 25 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD/EPI) formula or a quantified creatinine clearance >25 mL/min, and/or serum creatinine <3.0 mg/dL in the presence of ACEi/ARB therapy
- Adequate bone marrow function, as indicated by hemoglobin >7.0 gm/dL, white count >3.0 x 10(9), platelet count >100 x 10(9)
- Negative chest x-ray within one year
- Negative serum pregnancy test (for women of child bearing age)
- Normal organ function.
- Subject agrees to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
- Subject has provided written informed consent
- Subject agrees to discontinue routine use of non-steroidal anti-inflammatory drugs
- Absolute Neutrophil Count (ANC): > 1000/ mm3
- Adequate liver function, as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and total bilirubin < 2x upper limit or normal unless related to primary disease
- Negative HBsAg and anti-hepatitis B (HBc) lab values within 1 year of signing consent
Who cannot join
- Pregnancy (determined by a serum pregnancy test for all women of childbearing potential within 7 days of treatment), or lactating.
- Inability to comply with study and/or follow-up procedures
- History of HIV (a documented positive lab value within one year of enrollment)
- Presence of active infection
- New York Heart Association Classification III or IV heart disease
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
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- History of psychiatric disorder
- At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to randomization
- At the Investigator's discretion, positive Hepatitis C serology
- Known history of diabetes mellitus or a Hemoglobin A1c result > 6.0% within 90 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis
This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug.
Read the detailed description
This is a Phase II, open-label pilot study to determine if the use of Rituximab reduces proteinuria over a 12 month period and is there preservation of kidney function with the use of this study drug. Each patient will be treated with 2 intravenous infusions of rituximab 1000 mg, two weeks apart for a total of 2 doses. Each patient will be retreated with identical 2 intravenous infusions of rituximab, two weeks apart at 6 months after the first infusion, irrespective of cluster of differentiation (CD) 20+ cell counts. Thus, each participant will receive 4 infusions of rituximab.
- Conditions
- Fibrillary Glomerulonephritis
- Being tested
- rituximab
- Keywords
- fibrillary glomerulonephritis, rituximab, Rituxan, MabThera, Zytux™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called Rituxan
1000 mg infusion
| Study group | Role | What they receive |
|---|---|---|
| rituximab | Experimental | rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions. Receives: Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24 Hour Creatinine Clearance
Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).
Measured: Day 0, Day 365
Secondary outcomes (1)
Change in Proteinuria
Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.
Measured: Day 0, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibrillary GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Stephen B. Erickson, M.D., Mayo Clinic
- Investigators
- Stephen B. Erickson, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197767
- Sponsor's protocol ID
- 13-006694
- Status last verified
- Jan 2019
- First submitted
- 21 Jul 2014
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Erickson SB, Zand L, Nasr SH, Alexander MP, Leung N, Drosou ME, Fervenza FC. Treatment of fibrillary glomerulonephritis with rituximab: a 12-month pilot study. Nephrol Dial Transplant. 2021 Jan 1;36(1):104-110. doi: 10.1093/ndt/gfaa065.
PubMed 32617582
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis
- ClinicalTrials.gov ID
- NCT02197767
- Acronym / sponsor ID
- 13-006694
- Conditions
- Fibrillary Glomerulonephritis
- Keywords
- fibrillary glomerulonephritis, rituximab, Rituxan, MabThera, Zytux™
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Posted 6 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug.
Detailed description
This is a Phase II, open-label pilot study to determine if the use of Rituximab reduces proteinuria over a 12 month period and is there preservation of kidney function with the use of this study drug. Each patient will be treated with 2 intravenous infusions of rituximab 1000 mg, two weeks apart for a total of 2 doses. Each patient will be retreated with identical 2 intravenous infusions of rituximab, two weeks apart at 6 months after the first infusion, irrespective of cluster of differentiation (CD) 20+ cell counts. Thus, each participant will receive 4 infusions of rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab | Experimental | Drug: rituximabrituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Fibrillary Glomerulonephritis with diagnostic biopsy performed within the last 2 years
- Proteinuria >1 gram
- Age > 18 years but < 80 years
- Adequately controlled blood pressure (BP<140/90 mmHg in >75% of the readings) for at least 3 months prior to enrollment with the use of (angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin-receptor blockers (ARB), if tolerated.
- Women must be post- menopausal, surgically sterile or practicing a medically approved method of contraception
Key exclusion criteria (10 listed)
- Pregnancy (determined by a serum pregnancy test for all women of childbearing potential within 7 days of treatment), or lactating.
- Inability to comply with study and/or follow-up procedures
- History of HIV (a documented positive lab value within one year of enrollment)
- Presence of active infection
- New York Heart Association Classification III or IV heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabAlso: Rituxan1000 mg infusion | Drug | rituximab |
Primary outcome
Change in 24 Hour Creatinine Clearance
Time frame: Day 0, Day 365
Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).
1 secondary outcome
Change in Proteinuria
Time frame: Day 0, Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32617582Erickson SB, Zand L, Nasr SH, Alexander MP, Leung N, Drosou ME, Fervenza FC. Treatment of fibrillary glomerulonephritis with rituximab: a 12-month pilot study. Nephrol Dial Transplant. 2021 Jan 1;36(1):104-110. doi: 10.1093/ndt/gfaa065.
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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.
Stephen B. Erickson, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab in people with Fibrillary Glomerulonephritis, run by Mayo Clinic at 1 site in United States.
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 17 inclusion and 10 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 6 Feb 2019. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in 24 Hour Creatinine Clearance (time frame: Day 0, Day 365). 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 NCT02197767, 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 6 Feb 2019.