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Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1 (BEST-IgAN-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357653
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
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
Information provided by (Responsible Party):
Ewha Womans University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, Immunoglobulin A (IgA) Drug: Losartan group Drug: Placebo group Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 30, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Losartan group
Losartan 50 mg daily
Drug: Losartan group
Losartan 50 mg daily
Other Name: Losartan

Placebo Comparator: Placebo group
Placebo 1 pill daily which has same size, color and taste with losartan
Drug: Placebo group
Placebo 1 pill daily
Other Name: Placebo




Primary Outcome Measures :
  1. Significant proteinuria rate [ Time Frame: 144 weeks after study started ]
    Random urine protein-to-creatinine ratio >= 1g/g creatinine


Secondary Outcome Measures :
  1. Proteinuria remission rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study started ]
    Random urine protein-to-creatinine ratio < 0.20 g/g creatinine

  2. Impaired kidney function rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study started ]
    estimated glomerular filtration rate decline >= 40% from the baseline value

  3. Hypertension development rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study started ]
    Systolic blood pressure >= 140 or diastolic blood pressure >= 90



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
  2. Age >= 19 years
  3. Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
  4. Estimated glomerular filtration rate >= 60 mL/min/1.73m2 at visit 1
  5. People who voluntarily agreed to participate
  6. People who are compliant

Exclusion Criteria:

  1. Prevalent Hypertension: systolic blood pressure >=140 mmHg and >=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
  2. Prevalent Diabetes: fasting glucose >= 126 mg/dL, HbA1c >= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
  3. Previous immunosuppressive drugs use to treat IgAN
  4. Secondary IgAN
  5. Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
  6. hypersensitivity to RASI
  7. Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease
  8. Pregnancy
  9. symptomatic orthostatic hypotension
  10. People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
  11. Inappropriate people ascertained by investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357653


Contacts
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Contact: Dong-Ryeol Ryu, Professor 82-2-2650-2507 drryu@ewha.ac.kr

Sponsors and Collaborators
Ewha Womans University
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
Investigators
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Principal Investigator: Dong-Ryeol Ryu, Professor Ewha Womans University
  Study Documents (Full-Text)

Documents provided by Ewha Womans University:
Publications:

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Responsible Party: Ewha Womans University
ClinicalTrials.gov Identifier: NCT03357653    
Other Study ID Numbers: BEST-IGAN-001
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ewha Womans University:
proteinuria
progression
early immunoglobulin A (IgA) nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis
Urologic Diseases
Nephritis
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action