Clareo Health | The MIMIGA Study is a Randomized, Double-blind, Placebo-controlled Crossover Trial Evaluating the Safety and Efficacy of SCFA vs. Placebo. Administered Orally Once Daily With Standard Care, it Aims to Prevent CKD Progression in Biopsy-proven IgA Nephropathy by Modulating the Gut Microbiome.
The MIMIGA Study is a Randomized, Double-blind, Placebo-controlled Crossover Trial Evaluating the Safety and Efficacy of SCFA vs. Placebo. Administered Orally Once Daily With Standard Care, it Aims to Prevent CKD Progression in Biopsy-proven IgA Nephropathy by Modulating the Gut Microbiome.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Martin
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- Subjects aged 18 and older at the time of signing the informed consent form (ICF) before initiating any study specific activities/procedures.
Biopsy-proven IgA nephropathy.
Receiving a maximally tolerated and stable dose of RAS inhibitor therapy (ACEi or ARB) for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and stable dose.
eGFR of at least 30 ml/min/1.73 m2 at screening based on the CKD-EPI equation.
Willing and able to provide informed consent and comply with all study requirements.
Receiving a stable dose of an SGLT2i for at least eight weeks prior to screening
Must have the spot morning urine protein-creatinine ratio \> 500 mg/g
Must have the spot morning urine protein-creatinine ratio \> 850 mg/g at screening
Must have completed the 8-week run-in period on a stable and well-tolerated dose of an SGLT2i
Must have the spot morning urine protein-creatinine ratio \> 500 mg/g confirmed at the Week -1 Visit
Must have an eGFR of ≥ 30 ml/min/1.73 m2 based on the CKD-EPI equation at the Week -1 Visit
Receiving treatment with SGLT2i at a stable dose for at least eight weeks prior to screening.
You may not be if
current diagnosis with another chronic kidney disease, including diabetic kidney disease,secondary IgAN, type 1 or 2 diabetes mellitus
gastrointestinal diseases (such as IBD, peptic ulcers etc.),
another immunological or autoimmune disorders
alcohol abuse
psychiatric disease and inability to assess follow-up
+history of kidney transplantation or another organ transplantation,
use of systemic immunosuppressant medications, such as steroids, in the past 3 months, use of ATB in the past three months
blood pressure above 150 mmHg systolic or 95 mmHg diastolic
clinically significant history of liver disease (aspartate transaminase \[AST\] or alanine ttransaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment)
For women - pregnancy, breastfeeding, or intent to become pregnant during the study
For men - intent to father a child or donate sperm during the study
If the patient has received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) within one month (or five half-lives of the agent, whichever is longer) prior to Screening, if the investigational agent is a cytotoxic or mmunosuppressive, then this washout period is six months
