One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Summary

This is a prospective, single-center, single-arm, open-label study investigating the safety, compliance and pharmacokinetics of 1-month treatment of Isoniazid, Rifapentine and Vitamin B6 in renal transplant candidates.

Timeline

Start

2022-07-01

Primary completion

2026-01-16

Completion

2029-06-30

Publications

• Background Singh N, Paterson DL. Mycobacterium tuberculosis infection in solid-organ transplant recipients: impact and implications for management. Clin Infect Dis. 1998 Nov;27(5):1266-77. doi: 10.1086/514993.
• Background Subramanian A, Dorman S; AST Infectious Diseases Community of Practice. Mycobacterium tuberculosis in solid organ transplant recipients. Am J Transplant. 2009 Dec;9 Suppl 4:S57-62. doi: 10.1111/j.1600-6143.2009.02894.x. No abstract available.
• Background Adamu B, Abdu A, Abba AA, Borodo MM, Tleyjeh IM. Antibiotic prophylaxis for preventing post solid organ transplant tuberculosis. Cochrane Database Syst Rev. 2014 Mar 4;2014(3):CD008597. doi: 10.1002/14651858.CD008597.pub2.
• Background Agarwal SK, Gupta S, Dash SC, Bhowmik D, Tiwari SC. Prospective randomised trial of isoniazid prophylaxis in renal transplant recipient. Int Urol Nephrol. 2004;36(3):425-31. doi: 10.1007/s11255-004-6251-6.
• Background Rafiei N, Williams J, Mulley WR, Trauer JM, Jenkin GA, Rogers BA. Mycobacterium tuberculosis: Active disease and latent infection in a renal transplant cohort. Nephrology (Carlton). 2019 May;24(5):569-574. doi: 10.1111/nep.13386.
• Background van den Boogaard J, Kibiki GS, Kisanga ER, Boeree MJ, Aarnoutse RE. New drugs against tuberculosis: problems, progress, and evaluation of agents in clinical development. Antimicrob Agents Chemother. 2009 Mar;53(3):849-62. doi: 10.1128/AAC.00749-08. Epub 2008 Dec 15. No abstract available.
• Background Zhang T, Zhang M, Rosenthal IM, Grosset JH, Nuermberger EL. Short-course therapy with daily rifapentine in a murine model of latent tuberculosis infection. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1151-7. doi: 10.1164/rccm.200905-0795OC. Epub 2009 Sep 3.
• Background Holland DP, Sanders GD, Hamilton CD, Stout JE. Potential economic viability of two proposed rifapentine-based regimens for treatment of latent tuberculosis infection. PLoS One. 2011;6(7):e22276. doi: 10.1371/journal.pone.0022276. Epub 2011 Jul 18.
• Background Swindells S, Ramchandani R, Gupta A, Benson CA, Leon-Cruz J, Mwelase N, Jean Juste MA, Lama JR, Valencia J, Omoz-Oarhe A, Supparatpinyo K, Masheto G, Mohapi L, da Silva Escada RO, Mawlana S, Banda P, Severe P, Hakim J, Kanyama C, Langat D, Moran L, Andersen J, Fletcher CV, Nuermberger E, Chaisson RE; BRIEF TB/A5279 Study Team. One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis. N Engl J Med. 2019 Mar 14;380(11):1001-1011. doi: 10.1056/NEJMoa1806808.

Drugs

Indications