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Compares treatment options for IgA Nephropathy
Official title Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?
ClinicalTrials.gov ID: NCT06676384
What this study is testing
What is Oral prednisolone and SoC?
Oral prednisolone and SoC is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for iga nephropathy.
Also referred to as Wysolone® by Pfizer Ltd..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Global Burden of Diseases ranks chronic kidney disease (CKD) as the 12th leading cause of death, with an estimated 20% increase from 2010 to 2019. India is the most populous country in South Asia, with one-fourth of the global population.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Must be able to provide a written informed consent form, which must be obtained before the initiation of study assessments.
- Adults between 18-65 years of age.
- Males or Females.
- Diagnosis of primary IgAN as demonstrated by renal biopsy of any vintage if eGFR ≥45 mL/min/1.73 m2 or within the last ten years if eGFR \<45...
- eGFR ≥20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
You likely can't join if
- IgAN secondary to another condition (e.g., liver cirrhosis) or other causes of mesangial IgA deposition such as systemic lupus erythematosus (SLE)...
- Evidence of nephrotic syndrome at screening (serum albumin \ 3.5 g/g).
- Evidence of rapidly progressive glomerulonephritis defined as loss of ≥ 50% of eGFR in three months before screening.
- Concomitant kidney disease in addition to IgAN in kidney biopsy (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous...
- Female patients planning pregnancy.
- Concomitant co-morbidities like systemic autoimmune disorders, chronic active infections like tuberculosis, hepatitis B, hepatitis C and human...
See the full eligibility criteria
- Must be able to provide a written informed consent form, which must be obtained before the initiation of study assessments.
- Adults between 18-65 years of age.
- Males or Females.
- Diagnosis of primary IgAN as demonstrated by renal biopsy of any vintage if eGFR ≥45 mL/min/1.73 m2 or within the last ten years if eGFR \<45 mL/min/1.73 m2. If diabetic, the biopsy vintage should be less than five...
- eGFR ≥20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Total urine protein excretion ≥1 g per 24-hour or UPCR ≥ 0.75 g/g from an adequately measured 24-hour urine sample (24HUP) during the Screening Period.
- Patient on the maximum labelled or tolerated dose of ACEi or ARB AND 10mg/d of Dapagliflozin (SGLT2i) for at least 12 weeks at screening and from screening to study Day 1.
- Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 mmHg at randomisation. Other anti-hypertensives can be optimised during the screening period to achieve the BP goal.
- A female is eligible if she is not pregnant and consents to avoid pregnancy during the study duration.
- IgAN secondary to another condition (e.g., liver cirrhosis) or other causes of mesangial IgA deposition such as systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis, etc. IgA vasculitis...
- Evidence of nephrotic syndrome at screening (serum albumin \ 3.5 g/g).
- Evidence of rapidly progressive glomerulonephritis defined as loss of ≥ 50% of eGFR in three months before screening.
- Concomitant kidney disease in addition to IgAN in kidney biopsy (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis).
- Female patients planning pregnancy.
- Concomitant co-morbidities like systemic autoimmune disorders, chronic active infections like tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus infection, chronic liver disease, and chronic...
- Renal or other organ transplantation before, or expected during, the study, except for corneal transplants.
- Morbid obesity defined as BMI ≥ 40 kg/m2 at screening.
- Uncontrolled diabetes as defined by HbA1c \> 8% at screening.
- History or diagnosis of demyelinating diseases such as multiple sclerosis or optic neuritis.
- Prohibited medications:
- Participants who received oral steroids over two weeks within 12 weeks before screening.
- Immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for treating IgAN within 12 weeks before screening.
- Use of B-cell-directed biologic therapies, including belimumab, rituximab, and ocrelizumab, within six months before screening.
- Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics within the last four weeks or five half-lives, whichever is longer, before the screening.
- Use of traditional medications and/or Ayurvedic medications within 12 weeks before screening.
- Use of endothelin receptor antagonists/ oral spironolactone or oral finerenone/ GLP-1 agonists/ hydroxychloroquine within 12 weeks before screening.
- Patients with a history of unstable angina, Class III and IV congestive heart failure, and clinically significant arrhythmia, as judged by the Investigator.
- Active clinically significant viral, bacterial, or fungal infection or any major episode of infection requiring hospitalisation or treatment with parenteral anti-infectives within four weeks before or during the...
- History of malignancy within the past five years before Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence...
- Known hypersensitivity to any of the interventions.
- Major surgery within six weeks before the Screening Visit.
- Clinically significant history of alcohol or drug abuse in the one year before the Screening Visit as per the Investigator's opinion.
- Unwillingness or lack of capacity to follow all study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Nadiād, Gujarat, India
- Mysuru, Karnataka, India
- Udupi, Karnataka, India
- Mumbai, Maharashtra, India
- Delhi, New Delhi, India
- Bhubaneswar, Odisha, India
- Puducherry, Puducherry, India
- Chennai, Tamil Nadu, India
- Vellore, Tamil Nadu, India
- Hyderabad, Telangana, India
- Lucknow, Uttar Pradesh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nadiād, Gujarat, India; Mysuru, Karnataka, India; Udupi, Karnataka, India; Mumbai, Maharashtra, India; Delhi, New Delhi, India; Bhubaneswar, Odisha, India and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.