NIH-funded research R01 grant

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.

More Pharmacokinetics research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionDuke University
NIH-funded
Lab location1 site (Durham, United States)
Project startJuly 6, 2026
Project endMarch 31, 2031
Funding year2026
Award (this year)$658,859
NIH project number1R01AR087482-01
Project IDNIH-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

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.