Our prospective observational ‘Glomerular Research And Clinical Experiments- IgA Nephropathy in Indians’ (GRACE-IgANI) cohort Since 2015, our team has been studying IgA nephropathy (IgAN) in South Asian individuals to understand how the disease progresses. Since 2015, our team has been studying IgA nephropathy (IgAN) in South Asian individuals to understand how the disease progresses. So far, our research (the GRACE-IgANI study) has shown that this kidney condition can affect people quickly in South Asian population.
India Alliance GRACE-IgAN platform trial was conducted in Christian Medical College, Vellore, as a principal coordinating center involved in the design, implementation, co- ordination, formation and management, along with multiple center’s under the supervision of Consultant Nephrologist, Dr. Suceena Alexander (M.D., D.M., FRCP (Lon.), FASN,), who intiated the GRACE IgA platform trial network for glomerular diseases, and this clinical trial aimed at individuals diagnosed with IgA Nephropathy (IgAN) and confirmed with kidney biopsy. Globally various healthcare experts, senior consultants and committee members in field of Nephrology are actively participating in this trial and providing their insights and valuable suggestions. It is an Multi-arm Multi-stage platform trial, a real-world pragmatic trial being used for the first time in proteinuric kidney diseases, which will investigate the commonly available and Food and Drug Administration approved drugs which are globally used for renal disease such as SGLT2 inhibitors, Hydroxychloroquine (HCQ), Mycophenolate mofetil (MMF), and Oral prednisolone, when combined with the Standard of Care protocol in IgA patients in South Asian population.
Age criteria
Participants who are between 18 to 65 years.
Disease criteria
Kidney biopsy proven primary IgA Nephropathy.
Medication criteria
On a stable, prescribed regimen of an ACE inhibitor or ARB medication for blood pressure.
SGLT2i=Sodium-Glucose Cotransporter-2 inhibitors; ACE = Angiotensin-converting enzyme; ARB = Angiotensin receptor blocker
What will happen during the study period?
Screening
Visit your clinic to confirm your eligibility for enrollment in the trial
Review and Sign the informed Consent
If the doctor thinks your eligible, we will looking forward your consent and willing to participate in this trial
Randomization and Dosing
Upon your willing & consent to participate in this study, You are randomly assign you to one of our treatment options with medication
Follow-up period (24 months)
People who take part in this clinical trial (participants) will be given the clinical trial treatment for about 2 years. After your enrollment, participant's need to visit the hospital at every three months. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have.Assessments' were done during hospital visit, which includes Medical & Physical Examination, Blood Pressure Measurement, Blood & Urine test, Medication adherence.
Voluntary Participation
Taking part in a research study is your willing. You can ask any questions you want, and you're free to stop being in the study whenever you want, for any reason
