Glomerulonephritis, IGAPhase 3NCT05510323
Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
A Phase 3 study testing Prednisolone and Prednisolone plus Cyclophosphamide in people with Glomerulonephritis, IGA, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerulonephritis, IGA
- What is being tested?
- Prednisolone and Prednisolone plus Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Biopsy-proven IgA nephropathy;
- Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
- Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.
Who cannot join
- Indication or contraindication for immunosuppressive therapy with corticosteroids
- Use of corticosteroids and other immunosuppressive drugs within the last 1 year
- Current unstable kidney function for other reasons
- Under 18 years old
- Patients with secondary IgAN
- Patients who are unlikely to comply with the study protocol in the view of the treating physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
AFMMU
Xi'an
Shiren Sun, 84775197, jiaqing0808@163.com
About this study
Official title: Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.
- Conditions
- Glomerulonephritis, IGA
- Being tested
- Prednisolone, Prednisolone plus Cyclophosphamide
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
RAS blockade as much as tolerated or allowed
Prednisolone plus CyclophosphamideDrug
RAS blockade as much as tolerated or allowed
| Study group | Role | What they receive |
|---|---|---|
| CS | Active comparator | low-dose corticosteroids monotherapy Receives: Drug: Prednisolone |
| CS+CTX | Active comparator | low-dose corticosteroids combined with cyclophosphamide Receives: Drug: Prednisolone plus Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined event
40% decrease in eGFR, ESRD or death due to kidney disease
Measured: up to 6 years
Secondary outcomes (11)
Proteinuria remission at 6, 12 months and total follow-up period
Proteinuria remission
Measured: up to 6 years
Hematuria remission at 6, 12 months and total follow-up period
Hematuria remission
Measured: up to 6 years
The composite of 30% decrease in eGFR, ESRD and all cause death
Measured: up to 6 years
The composite of 40% decrease in eGFR, ESRD and all cause death
Measured: up to 6 years
The composite of 50% decrease in eGFR, ESRD and all cause death
Measured: up to 6 years
Annual eGFR decline rate
Measured: up to 6 years
30% decrease in eGFR
Measured: up to 6 years
40% decrease in eGFR
Measured: up to 6 years
50% decrease in eGFR
Measured: up to 6 years
ESRD
Measured: up to 6 years
All cause death
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Feb 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, IGAStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510323
- Sponsor's protocol ID
- KY20222108-F-1
- Status last verified
- May 2024
- First submitted
- 18 Aug 2022
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05510323
- Acronym / sponsor ID
- KY20222108-F-1
- Conditions
- Glomerulonephritis, IGA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Aug 2022 (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.
The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS | Active comparator | Drug: Prednisolonelow-dose corticosteroids monotherapy |
| CS+CTX | Active comparator | Drug: Prednisolone plus Cyclophosphamidelow-dose corticosteroids combined with cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven IgA nephropathy;
- Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
- Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.
Key exclusion criteria (6 listed)
- Indication or contraindication for immunosuppressive therapy with corticosteroids
- Use of corticosteroids and other immunosuppressive drugs within the last 1 year
- Current unstable kidney function for other reasons
- Under 18 years old
- Patients with secondary IgAN
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 |
|---|---|---|
| PrednisoloneRAS blockade as much as tolerated or allowed | Drug | CS |
| Prednisolone plus CyclophosphamideRAS blockade as much as tolerated or allowed | Drug | CS+CTX |
Primary outcome
Combined event
Time frame: up to 6 years
40% decrease in eGFR, ESRD or death due to kidney disease
11 secondary outcomes
Proteinuria remission at 6, 12 months and total follow-up period
Time frame: up to 6 years
Hematuria remission at 6, 12 months and total follow-up period
Time frame: up to 6 years
The composite of 30% decrease in eGFR, ESRD and all cause death
Time frame: up to 6 years
The composite of 40% decrease in eGFR, ESRD and all cause death
Time frame: up to 6 years
The composite of 50% decrease in eGFR, ESRD and all cause death
Time frame: up to 6 years
Annual eGFR decline rate
Time frame: up to 6 years
30% decrease in eGFR
Time frame: up to 6 years
40% decrease in eGFR
Time frame: up to 6 years
50% decrease in eGFR
Time frame: up to 6 years
ESRD
Time frame: up to 6 years
All cause death
Time frame: up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Related trials for Glomerulonephritis, IGA
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone and Prednisolone plus Cyclophosphamide in people with Glomerulonephritis, IGA, run by Air Force Military Medical University, China at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 6 May 2024. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined event (time frame: up to 6 years). 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 6 May 2024.