Glomerulonephritis, Immunoglobulin A (IgA)Phase 3BEST-IgAN-1NCT03357653
Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1
A Phase 3 study testing Losartan group in people with Glomerulonephritis, Immunoglobulin A (IgA), run by Ewha Womans University.
Trial summary
Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria >1g/g creatinine), impaired kidney function, or elevated blood pressure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glomerulonephritis, Immunoglobulin A (IgA)
- What is being tested?
- Losartan group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2018to 31 Dec 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
- Age >= 19 years
- Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
- Estimated glomerular filtration rate >= 60 mL/min/1.73m2 at visit 1
- People who voluntarily agreed to participate
- People who are compliant
Who cannot join
- Prevalent Hypertension: systolic blood pressure >=140 mmHg and >=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
- Prevalent Diabetes: fasting glucose >= 126 mg/dL, HbA1c >= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
- Previous immunosuppressive drugs use to treat IgAN
- Secondary IgAN
- Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
- hypersensitivity to RASI
Show all 11Show fewer
- Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease
- Pregnancy
- symptomatic orthostatic hypotension
- People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
- Inappropriate people ascertained by investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double Blinded, Placebo-controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Losartan in Early Immunoglobulin A Nephropathy (IgAN) Patients
Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria >1g/g creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40% of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN ultimately developed a significant proteinuria and hypertension in 10 years. Therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of ARB may be beneficial in preventing the significant proteinuria development in early IgAN patients. To prove the hypothesis, the investigators plan the current interventional study.
- Being tested
- Losartan group, Placebo group
- Keywords
- proteinuria, progression, early immunoglobulin A (IgA) nephropathy
- Medical subject headings
- Glomerulonephritis, Proteinuria, Disease Progression, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan groupDrug
Also called Losartan
Losartan 50 mg daily
Placebo groupDrug
Also called Placebo
Placebo 1 pill daily
| Study group | Role | What they receive |
|---|---|---|
| Losartan group | Experimental | Losartan 50 mg daily Receives: Drug: Losartan group |
| Placebo group | Placebo comparator | Placebo 1 pill daily which has same size, color and taste with losartan Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant proteinuria rate
Random urine protein-to-creatinine ratio >= 1g/g creatinine
Measured: 144 weeks after study started
Secondary outcomes (3)
Proteinuria remission rate
Random urine protein-to-creatinine ratio < 0.20 g/g creatinine
Measured: 48 weeks, 96 weeks, and 144 weeks after study started
Impaired kidney function rate
estimated glomerular filtration rate decline >= 40% from the baseline value
Measured: 48 weeks, 96 weeks, and 144 weeks after study started
Hypertension development rate
Systolic blood pressure >= 140 or diastolic blood pressure >= 90
Measured: 48 weeks, 96 weeks, and 144 weeks after study started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start30 Jan 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, Immunoglobulin A (IgA)Studies 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
- Model description
- The investigators will test the effect of ARB to prevent the development of significant proteinuria, defined as random urine protein-to-creatinine ratio of \>1g/g creatinine. In this study, the investigators choose losartan as a testing ARB. The investigators will compare the rate of significant proteinuria development between 2 arms, namely losartan group and placebo group after 144 weeks' treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea, Kyung Hee University Hospital at Gangdong, Kyungpook National University Hospital, Korea University Guro Hospital, SMG-SNU Boramae Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Ajou University School of Medicine, Pusan National University Yangsan Hospital, Severance Hospital, Eulji General Hospital, National Health Insurance Service Ilsan Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Kangdong Sacred Heart Hospital, Hallym University Medical Center, Gangnam Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Dong-Ryeol Ryu, Professor, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357653
- Sponsor's protocol ID
- BEST-IGAN-001
- Acronym
- BEST-IgAN-1
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li PK, Kwan BC, Chow KM, Leung CB, Szeto CC. Treatment of early immunoglobulin A nephropathy by angiotensin-converting enzyme inhibitor. Am J Med. 2013 Feb;126(2):162-8. doi: 10.1016/j.amjmed.2012.06.028.
PubMed 23331443Jo YI, Na HY, Moon JY, Han SW, Yang DH, Lee SH, Park HC, Choi HY, Lim SD, Kie JH, Lee YK, Shin SK. Effect of low-dose valsartan on proteinuria in normotensive immunoglobulin A nephropathy with minimal proteinuria: a randomized trial. Korean J Intern Med. 2016 Mar;31(2):335-43. doi: 10.3904/kjim.2014.266. Epub 2016 Feb 15.
PubMed 26874511Nieuwhof C, Kruytzer M, Frederiks P, van Breda Vriesman PJ. Chronicity index and mesangial IgG deposition are risk factors for hypertension and renal failure in early IgA nephropathy. Am J Kidney Dis. 1998 Jun;31(6):962-70. doi: 10.1053/ajkd.1998.v31.pm9631840.
PubMed 9631840Lai FM, Szeto CC, Choi PC, Li PK, Chan AW, Tang NL, Lui SF, Wang AY, To KF. Characterization of early IgA nephropathy. Am J Kidney Dis. 2000 Oct;36(4):703-8. doi: 10.1053/ajkd.2000.17614.
PubMed 11007671Szeto CC, Lai FM, To KF, Wong TY, Chow KM, Choi PC, Lui SF, Li PK. The natural history of immunoglobulin a nephropathy among patients with hematuria and minimal proteinuria. Am J Med. 2001 Apr 15;110(6):434-7. doi: 10.1016/s0002-9343(01)00659-3.
PubMed 11331053Shen P, He L, Li Y, Wang Y, Chan M. Natural history and prognostic factors of IgA nephropathy presented with isolated microscopic hematuria in Chinese patients. Nephron Clin Pract. 2007;106(4):c157-61. doi: 10.1159/000104426. Epub 2007 Jun 26.
PubMed 17596724Lee H, Hwang JH, Paik JH, Ryu HJ, Kim DK, Chin HJ, Oh YK, Joo KW, Lim CS, Kim YS, Lee JP. Long-term prognosis of clinically early IgA nephropathy is not always favorable. BMC Nephrol. 2014 Jun 19;15:94. doi: 10.1186/1471-2369-15-94.
PubMed 24946688Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PubMed 38299639
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Placebo-controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Losartan in Early Immunoglobulin A Nephropathy (IgAN) Patients
- ClinicalTrials.gov ID
- NCT03357653
- Acronym / sponsor ID
- BEST-IgAN-1 / BEST-IGAN-001
- Keywords
- proteinuria, progression, early immunoglobulin A (IgA) nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Collaborators
- The Catholic University of Korea, Kyung Hee University Hospital at Gangdong, Kyungpook National University Hospital, Korea University Guro Hospital, SMG-SNU Boramae Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Ajou University School of Medicine, Pusan National University Yangsan Hospital, Severance Hospital, Eulji General Hospital, National Health Insurance Service Ilsan Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Kangdong Sacred Heart Hospital, Hallym University Medical Center, Gangnam Severance Hospital
- Study start
- 30 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Nov 2017 (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.
Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria >1g/g creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40% of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN ultimately developed a significant proteinuria and hypertension in 10 years. Therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of ARB may be beneficial in preventing the significant proteinuria development in early IgAN patients. To prove the hypothesis, the investigators plan the current interventional study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will test the effect of ARB to prevent the development of significant proteinuria, defined as random urine protein-to-creatinine ratio of >1g/g creatinine. In this study, the investigators choose losartan as a testing ARB. The investigators will compare the rate of significant proteinuria development between 2 arms, namely losartan group and placebo group after 144 weeks' treatment.
| Arm | Type | Receives |
|---|---|---|
| Losartan group | Experimental | Drug: Losartan groupLosartan 50 mg daily |
| Placebo group | Placebo comparator | Drug: Placebo groupPlacebo 1 pill daily which has same size, color and taste with losartan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
- Age >= 19 years
- Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
- Estimated glomerular filtration rate >= 60 mL/min/1.73m2 at visit 1
- People who voluntarily agreed to participate
Key exclusion criteria (11 listed)
- Prevalent Hypertension: systolic blood pressure >=140 mmHg and >=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
- Prevalent Diabetes: fasting glucose >= 126 mg/dL, HbA1c >= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
- Previous immunosuppressive drugs use to treat IgAN
- Secondary IgAN
- Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
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 |
|---|---|---|
| Losartan groupAlso: LosartanLosartan 50 mg daily | Drug | Losartan group |
| Placebo groupAlso: PlaceboPlacebo 1 pill daily | Drug | Placebo group |
Primary outcome
Significant proteinuria rate
Time frame: 144 weeks after study started
Random urine protein-to-creatinine ratio >= 1g/g creatinine
3 secondary outcomes
Proteinuria remission rate
Time frame: 48 weeks, 96 weeks, and 144 weeks after study started
Impaired kidney function rate
Time frame: 48 weeks, 96 weeks, and 144 weeks after study started
Hypertension development rate
Time frame: 48 weeks, 96 weeks, and 144 weeks after study started
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Background: PubMed 23331443Li PK, Kwan BC, Chow KM, Leung CB, Szeto CC. Treatment of early immunoglobulin A nephropathy by angiotensin-converting enzyme inhibitor. Am J Med. 2013 Feb;126(2):162-8. doi: 10.1016/j.amjmed.2012.06.028.
- Background: PubMed 26874511Jo YI, Na HY, Moon JY, Han SW, Yang DH, Lee SH, Park HC, Choi HY, Lim SD, Kie JH, Lee YK, Shin SK. Effect of low-dose valsartan on proteinuria in normotensive immunoglobulin A nephropathy with minimal proteinuria: a randomized trial. Korean J Intern Med. 2016 Mar;31(2):335-43. doi: 10.3904/kjim.2014.266. Epub 2016 Feb 15.
- Background: PubMed 9631840Nieuwhof C, Kruytzer M, Frederiks P, van Breda Vriesman PJ. Chronicity index and mesangial IgG deposition are risk factors for hypertension and renal failure in early IgA nephropathy. Am J Kidney Dis. 1998 Jun;31(6):962-70. doi: 10.1053/ajkd.1998.v31.pm9631840.
- Background: PubMed 11007671Lai FM, Szeto CC, Choi PC, Li PK, Chan AW, Tang NL, Lui SF, Wang AY, To KF. Characterization of early IgA nephropathy. Am J Kidney Dis. 2000 Oct;36(4):703-8. doi: 10.1053/ajkd.2000.17614.
- Background: PubMed 11331053Szeto CC, Lai FM, To KF, Wong TY, Chow KM, Choi PC, Lui SF, Li PK. The natural history of immunoglobulin a nephropathy among patients with hematuria and minimal proteinuria. Am J Med. 2001 Apr 15;110(6):434-7. doi: 10.1016/s0002-9343(01)00659-3.
- Background: PubMed 17596724Shen P, He L, Li Y, Wang Y, Chan M. Natural history and prognostic factors of IgA nephropathy presented with isolated microscopic hematuria in Chinese patients. Nephron Clin Pract. 2007;106(4):c157-61. doi: 10.1159/000104426. Epub 2007 Jun 26.
- Background: PubMed 24946688Lee H, Hwang JH, Paik JH, Ryu HJ, Kim DK, Chin HJ, Oh YK, Joo KW, Lim CS, Kim YS, Lee JP. Long-term prognosis of clinically early IgA nephropathy is not always favorable. BMC Nephrol. 2014 Jun 19;15:94. doi: 10.1186/1471-2369-15-94.
- Derived from this study: PubMed 38299639Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- 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.
Dong-Ryeol Ryu, Professor principal investigator
Ewha Womans University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan group in people with Glomerulonephritis, Immunoglobulin A (IgA), run by Ewha Womans University.
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 6 inclusion and 11 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Ryeol Ryu, Professor (82-2-2650-2507, drryu@ewha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant proteinuria rate (time frame: 144 weeks after study started). 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 NCT03357653, which also lists 8 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 30 Nov 2017.