Biopsy-proven IgA NephropathyPhase 4NCT03468972
Effect of Immunosuppression in IgA Nephropathy
A Phase 4 study testing Immunosuppressive treatment and intensive supportive care in people with Biopsy-proven IgA Nephropathy, run by Yonsei University at 1 site in South Korea.
Trial summary
IgA nephropathy (IgAN) is the most common glomerulonephritis worldwide, leading to end stage renal disease (ESRD) in up to 30 to 40% of patients with in a few decades after diagnosis. Several therapeutic options have been used in clinical practice. However, no treatments can completely stop the progression of IgAN. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Biopsy-proven IgA Nephropathy
- What is being tested?
- Immunosuppressive treatment and intensive supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2019to May 2023
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven IgA nephropathy within 5 years of enrollment
- Persistent proteinuria of UPCR ≥ 1.0 g/g creatinine during 12-week supportive care including RAS blockers
- baseline eGFR ≥ 30 ml/min/1.73 m2 assessed by CKD-EPI equation
Who cannot join
- Nephrotic syndrome, atypical IgA nephropathy
- Crescents ≥ 25%
- Overt pulmonary tuberculosis
- Malignancy within 5 years of enrollment
- Pregnancy or breast feeding
- Active hepatitis, chronic hepatitis, liver cirrhosis, HIV
Show all 12Show fewer
- Kidney transplant
- Current use of immunosuppressive treatment or prior use of immunosuppressive drugs within 1 year of enrollment
- Uncontrolled hypertension (> 160/100 mmHg)
- Aged < 19 years
- Secondary IgA nephropathy such as lupus nephritis, chronic liver disease, or Henoch-Schlein purpura
- Involvement of other clinical trials within 3 months of enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital
Seoul, 03722
Seung Hyeok Han, MD, Ph.D, 82-2-2228-1984, hansh@yuhs.ac
About this study
IgA nephropathy (IgAN) is the most common glomerulonephritis worldwide, leading to end stage renal disease (ESRD) in up to 30 to 40% of patients with in a few decades after diagnosis. Several therapeutic options have been used in clinical practice. However, no treatments can completely stop the progression of IgAN. Given the pathogenic mechanism of IgAN, many researchers have tried to treat patients with IgAN using immunosuppression such as corticosteroids. To date, there have been conflicting results on the effects of immunosuppression in IgAN. Earlier studies from Italian groups showed that corticosteroid treatment significantly attenuated kidney function decline and decreased the development of ESRD. Since then, the beneficial effects of corticosteroids have generally been accepted for treatment of IgAN particularly in patients with high degree of proteinuria > 1.0 g/day despite maximal conservative care during 3 to 6 months. However, a recent interventional study by German group, known as the Supportive Versus Immunosuppressive Therapy for the Treatment of Progressive IgA Nephropathy (STOP-IgAN) trial, showed that immunosuppressive treatment in addition to intensive supportive care did not significantly improve renal outcome and resulted in more treatment-related side effects. Moreover, the Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study, another randomized controlled study from China, was early terminated because of safety concern related to corticosteroids. Interestingly, the primary composite outcome occurred significantly less in the methylprednisolone group as compared to the placebo group despite more serious adverse events in the former group. With this background in mind, we designed a multicenter prospective randomized controlled open-label trial; a step-wise therapeutic approach with corticosteroids or add-on cyclophosphamide therapy in IgAN patients with persistent proteinuria who have preserved eGFR of ≥ 30 ml/min/1.73 m2. A total of 19 hospitals will participate in this study. During 12 weeks before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids. At 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. At least 87 subjects (a total of 174) would be required for each group to detect 13.5% difference in response rates between the two groups based on previous studies if type I error rate is 5% and type II error is 20% given 20% of drop-out rate during the study period. The primary endpoint is the development of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD. This study will unveil conflicting results on the effects of immunosuppressive treatment in IgAN patients at high risk of progression.
Read the detailed description
The investigators will conduct a multicenter prospective randomized controlled open-label trial; a step-wise therapeutic approach in IgAN patients with persistent proteinuria who have preserved eGFR of ≥ 30 ml/min/1.73 m2. During 3-6 months before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids. At 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. At least 87 subjects (a total of 174) would be required for each group to detect 13.5% difference in response rates between the two groups based on previous studies if type I error rate is 5% and type II error is 20% given 20% of drop-out rate during the study period.
- Conditions
- Biopsy-proven IgA Nephropathy
- Being tested
- Immunosuppressive treatment, intensive supportive care
- Keywords
- IgA nephropathy, immunosuppression
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppressive treatmentDrug
At 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. Assessment of outcome will be done at 6 months and at 36 months.
intensive supportive careOther
During 3-6 months before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression | Experimental | corticosteroids or cyclophosphamide added on corticosteroids Receives: Drug: Immunosuppressive treatment |
| Intensive supportive care | Active comparator | intensive supportive care with RAS blockers, blood pressure control, and protein restriction diet Receives: Other: intensive supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of disease
a composite of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD
Measured: 6 months
progression of disease
a composite of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD
Measured: 36 months
Secondary outcomes (2)
Changes in urinary protein excretion and hematuria
Measured: 6 months
Changes in urinary protein excretion and hematuria
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startMar 2019 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Biopsy-proven IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468972
- Sponsor's protocol ID
- 4-2018-0303
- Status last verified
- Feb 2019
- First submitted
- 12 Mar 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Manno C, Torres DD, Rossini M, Pesce F, Schena FP. Randomized controlled clinical trial of corticosteroids plus ACE-inhibitors with long-term follow-up in proteinuric IgA nephropathy. Nephrol Dial Transplant. 2009 Dec;24(12):3694-701. doi: 10.1093/ndt/gfp356. Epub 2009 Jul 23.
PubMed 19628647Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.
PubMed 26630142Lv J, Zhang H, Wong MG, Jardine MJ, Hladunewich M, Jha V, Monaghan H, Zhao M, Barbour S, Reich H, Cattran D, Glassock R, Levin A, Wheeler D, Woodward M, Billot L, Chan TM, Liu ZH, Johnson DW, Cass A, Feehally J, Floege J, Remuzzi G, Wu Y, Agarwal R, Wang HY, Perkovic V; TESTING Study Group. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):432-442. doi: 10.1001/jama.2017.9362.
PubMed 28763548Lv J, Zhang H, Chen Y, Li G, Jiang L, Singh AK, Wang H. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis. 2009 Jan;53(1):26-32. doi: 10.1053/j.ajkd.2008.07.029. Epub 2008 Oct 19.
PubMed 18930568Pozzi C, Bolasco PG, Fogazzi GB, Andrulli S, Altieri P, Ponticelli C, Locatelli F. Corticosteroids in IgA nephropathy: a randomised controlled trial. Lancet. 1999 Mar 13;353(9156):883-7. doi: 10.1016/s0140-6736(98)03563-6.
PubMed 10093981Tesar V, Troyanov S, Bellur S, Verhave JC, Cook HT, Feehally J, Roberts IS, Cattran D, Coppo R; VALIGA study of the ERA-EDTA Immunonephrology Working Group. Corticosteroids in IgA Nephropathy: A Retrospective Analysis from the VALIGA Study. J Am Soc Nephrol. 2015 Sep;26(9):2248-58. doi: 10.1681/ASN.2014070697. Epub 2015 Feb 12.
PubMed 25677392
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immunosuppression in IgA Nephropathy
- ClinicalTrials.gov ID
- NCT03468972
- Acronym / sponsor ID
- 4-2018-0303
- Conditions
- Biopsy-proven IgA Nephropathy
- Keywords
- IgA nephropathy, immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 19 Mar 2018 (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.
IgA nephropathy (IgAN) is the most common glomerulonephritis worldwide, leading to end stage renal disease (ESRD) in up to 30 to 40% of patients with in a few decades after diagnosis. Several therapeutic options have been used in clinical practice. However, no treatments can completely stop the progression of IgAN. Given the pathogenic mechanism of IgAN, many researchers have tried to treat patients with IgAN using immunosuppression such as corticosteroids. To date, there have been conflicting results on the effects of immunosuppression in IgAN. Earlier studies from Italian groups showed that corticosteroid treatment significantly attenuated kidney function decline and decreased the development of ESRD. Since then, the beneficial effects of corticosteroids have generally been accepted for treatment of IgAN particularly in patients with high degree of proteinuria > 1.0 g/day despite maximal conservative care during 3 to 6 months. However, a recent interventional study by German group, known as the Supportive Versus Immunosuppressive Therapy for the Treatment of Progressive IgA Nephropathy (STOP-IgAN) trial, showed that immunosuppressive treatment in addition to intensive supportive care did not significantly improve renal outcome and resulted in more treatment-related side effects. Moreover, the Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study, another randomized controlled study from China, was early terminated because of safety concern related to corticosteroids. Interestingly, the primary composite outcome occurred significantly less in the methylprednisolone group as compared to the placebo group despite more serious adverse events in the former group. With this background in mind, we designed a multicenter prospective randomized controlled open-label trial; a step-wise therapeutic approach with corticosteroids or add-on cyclophosphamide therapy in IgAN patients with persistent proteinuria who have preserved eGFR of ≥ 30 ml/min/1.73 m2. A total of 19 hospitals will participate in this study. During 12 weeks before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids. At 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. At least 87 subjects (a total of 174) would be required for each group to detect 13.5% difference in response rates between the two groups based on previous studies if type I error rate is 5% and type II error is 20% given 20% of drop-out rate during the study period. The primary endpoint is the development of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD. This study will unveil conflicting results on the effects of immunosuppressive treatment in IgAN patients at high risk of progression.
Detailed description
The investigators will conduct a multicenter prospective randomized controlled open-label trial; a step-wise therapeutic approach in IgAN patients with persistent proteinuria who have preserved eGFR of ≥ 30 ml/min/1.73 m2. During 3-6 months before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids. At 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. At least 87 subjects (a total of 174) would be required for each group to detect 13.5% difference in response rates between the two groups based on previous studies if type I error rate is 5% and type II error is 20% given 20% of drop-out rate during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression | Experimental | Drug: Immunosuppressive treatmentcorticosteroids or cyclophosphamide added on corticosteroids |
| Intensive supportive care | Active comparator | Other: intensive supportive careintensive supportive care with RAS blockers, blood pressure control, and protein restriction diet |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven IgA nephropathy within 5 years of enrollment
- Persistent proteinuria of UPCR ≥ 1.0 g/g creatinine during 12-week supportive care including RAS blockers
- baseline eGFR ≥ 30 ml/min/1.73 m2 assessed by CKD-EPI equation
Key exclusion criteria (12 listed)
- Nephrotic syndrome, atypical IgA nephropathy
- Crescents ≥ 25%
- Overt pulmonary tuberculosis
- Malignancy within 5 years of enrollment
- Pregnancy or breast feeding
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 |
|---|---|---|
| Immunosuppressive treatmentAt 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. Assessment of outcome will be done at 6 months and at 36 months. | Drug | Immunosuppression |
| intensive supportive careDuring 3-6 months before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids. | Other | Intensive supportive care |
Primary outcome
progression of disease
Time frame: 6 months
a composite of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD
progression of disease
Time frame: 36 months
a composite of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD
2 secondary outcomes
Changes in urinary protein excretion and hematuria
Time frame: 6 months
Changes in urinary protein excretion and hematuria
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Results publication: PubMed 19628647Manno C, Torres DD, Rossini M, Pesce F, Schena FP. Randomized controlled clinical trial of corticosteroids plus ACE-inhibitors with long-term follow-up in proteinuric IgA nephropathy. Nephrol Dial Transplant. 2009 Dec;24(12):3694-701. doi: 10.1093/ndt/gfp356. Epub 2009 Jul 23.
- Results publication: PubMed 26630142Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.
- Results publication: PubMed 28763548Lv J, Zhang H, Wong MG, Jardine MJ, Hladunewich M, Jha V, Monaghan H, Zhao M, Barbour S, Reich H, Cattran D, Glassock R, Levin A, Wheeler D, Woodward M, Billot L, Chan TM, Liu ZH, Johnson DW, Cass A, Feehally J, Floege J, Remuzzi G, Wu Y, Agarwal R, Wang HY, Perkovic V; TESTING Study Group. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):432-442. doi: 10.1001/jama.2017.9362.
- Results publication: PubMed 18930568Lv J, Zhang H, Chen Y, Li G, Jiang L, Singh AK, Wang H. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis. 2009 Jan;53(1):26-32. doi: 10.1053/j.ajkd.2008.07.029. Epub 2008 Oct 19.
- Results publication: PubMed 10093981Pozzi C, Bolasco PG, Fogazzi GB, Andrulli S, Altieri P, Ponticelli C, Locatelli F. Corticosteroids in IgA nephropathy: a randomised controlled trial. Lancet. 1999 Mar 13;353(9156):883-7. doi: 10.1016/s0140-6736(98)03563-6.
- Results publication: PubMed 25677392Tesar V, Troyanov S, Bellur S, Verhave JC, Cook HT, Feehally J, Roberts IS, Cattran D, Coppo R; VALIGA study of the ERA-EDTA Immunonephrology Working Group. Corticosteroids in IgA Nephropathy: A Retrospective Analysis from the VALIGA Study. J Am Soc Nephrol. 2015 Sep;26(9):2248-58. doi: 10.1681/ASN.2014070697. Epub 2015 Feb 12.
- 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.
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 Immunosuppressive treatment and intensive supportive care in people with Biopsy-proven IgA Nephropathy, run by Yonsei University at 1 site in South Korea.
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 12 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 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 South Korea. 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?
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?
progression of disease (time frame: 6 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 NCT03468972, which also lists 6 linked publications.
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 Feb 2019.