Azathioprine safety and dosing in pregnancy for mothers with autoimmune disease and their babies
Official title: Azathioprine Safety and Pharmacokinetics in Pregnant Women with Rheumatic Disease and their Infants
Funded at Duke University · NIH-11346965 · Data updated 2026-11-12
This study looks at how to safely use the drug azathioprine during pregnancy for women with autoimmune diseases and how it affects their infants.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | July 6, 2026 |
| Project end | March 31, 2031 |
| Funding year | 2026 |
| Award (this year) | $658,859 |
| NIH project number | 1R01AR087482-01 |
| Project ID | NIH-11346965 on NIH RePORTER |
Who could benefit from this research
✓Could help
Pregnant women (any trimester) with systemic lupus or other autoimmune diseases who are prescribed azathioprine.
✕Less likely to help
Patients not pregnant or not using azathioprine for autoimmune disease would not directly benefit.
What this research studies
Researchers at Duke University will follow pregnant women with systemic lupus or other autoimmune diseases who are taking azathioprine to understand how the drug behaves in the body during pregnancy and how different doses impact safety for both mother and baby. The project will track drug levels, liver-related side effects, and pregnancy outcomes to refine dosing guidelines. By combining pharmacokinetic data with maternal and infant health information, the study aims to identify dosing strategies that minimize risk while maintaining disease control. The findings could help clinicians personalize treatment for pregnant patients needing immunosuppression.
Why it matters
Potential benefit: If successful, the study could lead to safer, more precise dosing of azathioprine during pregnancy, improving outcomes for mothers and their newborns.
How similar studies have gone: There is limited comprehensive pharmacokinetic data in pregnancy; this study builds on observational signals and aims to provide systematic dosing guidance.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Balevic, Stephen Joseph — Duke University
- Study coordinator: Balevic, Stephen Joseph
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.