Short-course Rifamycin-based Regimens for Latent Tuberculosis in Patients With End-stage Kidney Disease

Launched by MIGUEL SANTÍN · Aug 24, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at different treatment options for latent tuberculosis (TB) in patients who have end-stage kidney disease, a serious condition where the kidneys can no longer function properly. The researchers want to find out if a 4-month treatment with rifampin or a 3-month treatment with rifapentine and isoniazid is more effective and better tolerated than the standard 3-month treatment with isoniazid alone. The study will include adults aged 18 and older who are diagnosed with severe kidney disease and can provide informed consent.

If you or a loved one participates in this trial, you will be randomly assigned to one of three treatment groups. You’ll take either the standard treatment or one of the two new treatments for a set period. Throughout the study, your health will be monitored to see if you can complete the treatment without stopping due to side effects or other reasons. Participation may help improve future treatment options for people with both latent TB and kidney disease, and your contribution could be valuable to medical research.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older
• • 2. Stage 5 kidney disease (glomerular filtrate rate \<15 mL/minute or under substitutive renal therapy
• • 3. Informed written consent
• Exclusion Criteria:
• • 1. Prior allergy/intolerance to rifamycins or isoniazid
• • 2. Pregnancy or breastfeeding
• • 3. Pre-treatment transaminases (ALT and/or AST) \>5-fold of normality titer
• • 4. Concomitant drugs contraindicated with rifamycins
• • 5. Having received rifamycins or isoniazid within the two previous weeks
• • 6. Weigh \<32 Kgs
• • 7. Inability to understand the nature of the study or to give written consent