Recurrent IgA NephropathyPhase 4NCT02571842
Rituximab in Recurrent IgA Nephropathy
A Phase 4 study testing Intravenous Rituximab and ACEI/ARB and corticosteroids in people with Recurrent IgA Nephropathy, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent IgA Nephropathy
- What is being tested?
- Intravenous Rituximab and ACEI/ARB and corticosteroids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent
- GFR by 24h Creatinine Clearance (CrCl) >30 ml/min/1.73m²
- Biopsy proven recurrent IgA nephropathy with endocapillary proliferation pattern
Who cannot join
- Clinical and histologic evidence of IgA combination with other forms of glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
- 24h CrCl <30 ml/min/1.73m² at the time of screening
- Active systemic infection or history of serious infection within one month of entry
- Positive pregnancy test or breast feeding at time of study entry
- Patients receiving >6 months therapy with oral prednisone >5mg/day or glucocorticoid equivalent
- Live vaccine within 28 days of study enrollment.
Trial locations and contacts
1 site in 1 country.
Wiwat Chancharoenthana, M.D., Ph.D. contact
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University
Bangkok, Bangkok, 10330
Wiwat Chancharoenthana, M.D., Ph.D., 6622564251 ext. 106, wiwatmd@hotmail.com
About this study
Official title: A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology
Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.
Read the detailed description
Hypothesis: In kidney transplant recipients with active endocapillary proliferation pathology of recurrent IgAN, an intravenous infusion of 375mg/m2 of rituximab on 4 consecutive monthly dose is superior to conventional therapy in reducing 24-hour proteinuria, and slowing progression of recurrent IgAN.
- Conditions
- Recurrent IgA Nephropathy
- Being tested
- Intravenous Rituximab, ACEI/ARB and corticosteroids
- Keywords
- Recurrent IgA nephropathy, Rituximab
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous RituximabDrug
Also called Mabthera
- 375 mg/m2 rituximab be prescribed 4 consecutive monthly
ACEI/ARB and corticosteroidsDrug
Also called "Enalapril", "Lorsartan", "Prednisolone
- ACEI or ARB will be prescribed as high as tolerable dose.
- Prednisolone will be prescribed starting as 0.5 mg/kg/day then taper off to 5 mg/day within 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab
•Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4
Other Name: Mabthera Receives: Drug: Intravenous Rituximab |
| ACEI/ARB plus corticosteroids | Active comparator | Drug: ACEI/ARB
* An ACEI and /or ARBs will be used to achieve proteinuria reduction and a blood pressure goal of <130/80 mmHg. Patients not attaining the target blood pressure with an ACEI or ARB alone should be treated with the combination of ACEI + ARB
* Corticosteroids will be used as prednisolone 0.5 mg/kg/day with gradually taper off in 6-8 weeks to 5mg/day daily
Other Name: Enalapril, Lorsartan, Prednisolone Receives: Drug: ACEI/ARB and corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate
Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance
Measured: 12 months
Incidence of all adverse events
The incidence of adverse events such as serious infection, allergy, fever, headache, etc.
Measured: 12 months
Secondary outcomes (1)
Change in allograft pathology following treatment
The difference of active and chronic score report by BANFF score, HAAS, Oxford criteria between pre-treatment and post-treatment
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 posted8 Oct 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent IgA NephropathyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiwat Chancharoenthana, Chulalongkorn University
- Investigators
- Wiwat Chancharoenthana, M.D., Ph.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571842
- Sponsor's protocol ID
- WWC-006
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology
- ClinicalTrials.gov ID
- NCT02571842
- Acronym / sponsor ID
- WWC-006
- Conditions
- Recurrent IgA Nephropathy
- Keywords
- Recurrent IgA nephropathy, Rituximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Oct 2015 (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.
Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.
Detailed description
Hypothesis: In kidney transplant recipients with active endocapillary proliferation pathology of recurrent IgAN, an intravenous infusion of 375mg/m2 of rituximab on 4 consecutive monthly dose is superior to conventional therapy in reducing 24-hour proteinuria, and slowing progression of recurrent IgAN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Intravenous RituximabDrug: Rituximab •Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4 Other Name: Mabthera |
| ACEI/ARB plus corticosteroids | Active comparator | Drug: ACEI/ARB and corticosteroidsDrug: ACEI/ARB * An ACEI and /or ARBs will be used to achieve proteinuria reduction and a blood pressure goal of <130/80 mmHg. Patients not attaining the target blood pressure with an ACEI or ARB alone should be treated with the combination of ACEI + ARB * Corticosteroids will be used as prednisolone 0.5 mg/kg/day with gradually taper off in 6-8 weeks to 5mg/day daily Other Name: Enalapril, Lorsartan, Prednisolone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent
- GFR by 24h Creatinine Clearance (CrCl) >30 ml/min/1.73m²
- Biopsy proven recurrent IgA nephropathy with endocapillary proliferation pattern
Key exclusion criteria (7 listed)
- Clinical and histologic evidence of IgA combination with other forms of glomerulonephritis
- Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
- 24h CrCl <30 ml/min/1.73m² at the time of screening
- Active systemic infection or history of serious infection within one month of entry
- Positive pregnancy test or breast feeding at time of study entry
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 |
|---|---|---|
| Intravenous RituximabAlso: Mabthera- 375 mg/m2 rituximab be prescribed 4 consecutive monthly | Drug | Rituximab |
| ACEI/ARB and corticosteroidsAlso: "Enalapril", "Lorsartan", "Prednisolone* ACEI or ARB will be prescribed as high as tolerable dose. * Prednisolone will be prescribed starting as 0.5 mg/kg/day then taper off to 5 mg/day within 6-8 weeks | Drug | ACEI/ARB plus corticosteroids |
Primary outcome
Remission rate
Time frame: 12 months
Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance
Incidence of all adverse events
Time frame: 12 months
The incidence of adverse events such as serious infection, allergy, fever, headache, etc.
1 secondary outcome
Change in allograft pathology following treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
Wiwat Chancharoenthana, M.D., Ph.D. contact
Wiwat Chancharoenthana, M.D., Ph.D. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Rituximab and ACEI/ARB and corticosteroids in people with Recurrent IgA Nephropathy, run by Chulalongkorn University at 1 site in Thailand.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Oct 2015. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wiwat Chancharoenthana, M.D., Ph.D. (wiwatmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate (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?
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 8 Oct 2015.