One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

NCT05411744 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro2018001735
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Latent Tuberculosis; End Stage Renal Disease; Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney

Keywords

Latent Tuberculosis; End Stage Renal Disease; Renal Transplant Candidate

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events with 1-m INH/RPT/Vit B6

  Treatment discontinuation due to adverse reaction of study drug determined by investigator

  28 days

Secondary Outcomes (2)

• Rate of treatment compliance

  28 days

• Rate of treatment completion

  28 days

Other Outcomes (3)

• Rate of reactivation of active tuberculosis

  2 years

• Trough drug concentration

  28 days

• 3-hour post-dose drug concentration

  28 days

Study Arms (1)

1 month Rifapentine, Isoniazid and Vitamin B6

OTHER

Participants will receive 28 days of self-administered daily doses of RPT, INH, and pyridoxine (vitamin B6). There are no multiple arms or multiple interventions. All participants will receive all 3 drugs. There are no comparators.

Drug: 1 month Rifapentine, Isoniazid and Vitamin B6

Interventions

1 month Rifapentine, Isoniazid and Vitamin B6 DRUG

Participants will be treated with one month (4 weeks) of daily Isoniazid, Rifapentine and Vitamin B6.

1 month Rifapentine, Isoniazid and Vitamin B6

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women Age \> 18
• Weight \> 30 kg
• End-stage renal disease
• Living-related or deceased kidney transplant candidate (not on the waitlist) deemed by their transplant nephrologist
• Negative serum OR urine pregnancy test
• Evidence of latent tuberculosis or high risk for tuberculosis: (1) Confirmed positive tuberculin skin test (TST) ≥ 5 mm or positive quantiferon gold test/T-spot and a chest radiograph or chest CT scan without evidence of active pulmonary TB OR (2) Patients with negative TST or quantiferon gold/T-spot test but high risk for tuberculosis are eligible if they have (i) radiographic evidence of previous TB (stable fibronodular changes, including scarring \[peribronchial fibrosis, bronchiectasis, and architectural distortion\] and nodular opacities in the apical and upper lung zones) and no history of adequate treatment, or (ii) have had close and prolonged contact with a case of active TB.

You may not qualify if:

• Age \<18 years
• Absolute neutrophil count of \<750 cells/mm3
• Hemoglobin \< 7.4 g/dL
• Platelets \< 50 x 10E3/uL
• AST (SGOT) and ALT (SGPT) \> 3 times the upper limit of normal (ULN)
• Total bilirubin \> 2.5 times the ULN
• Presence of active TB
• Prior history of treatment for active TB or LTBI
• Known exposure to multidrug-resistant TB
• Known history of or active porphyria
• History of liver cirrhosis
• Evidence of active acute hepatitis
• Peripheral neuropathy \> grade 2
• Active drug or alcohol dependence in opinion of investigator that will interfere with adherence
• On non-modifiable medications with significant drug interactions with Rifapentine or INH

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Pinki J Bhatt

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (9)

• 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.

  PMID: 9827281 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.

  PMID: 20070696 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.

  PMID: 24590589 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.

  PMID: 15783119 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.

  PMID: 29660203 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.

  PMID: 19075046 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.

  PMID: 19729664 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.

  PMID: 21789248 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.

  PMID: 30865794 BACKGROUND

MeSH Terms

Conditions

Latent Tuberculosis; Kidney Failure, Chronic

Interventions

rifapentine; Isoniazid; Vitamin B 6

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Picolines

Study Officials

• Pinki Bhatt, MD

  Rutgers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: July 1, 2022
• Primary Completion: January 16, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)