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

NCT ID: NCT05021731

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-04-30

Brief Summary

Objective To determine if treatment completion with a 4-month rifampin (4R) or 3-month rifapentine (P) + isoniazid (H) weekly for 12 weeks (3HP) regimens is better than with a 3-month (3HR) regimen for treatment of latent tuberculosis (TB) infection (LTBI) in patients with end stage kidney disease.

Methods Design: Multicenter, prospective, parallel-group, open-label, controlled clinical trial.

Study population: All adult patients with ESKD in who treatment for LTBI is prescribed at 7 hospitals.

Interventions: Patients who accept participation, will be randomly assigned to one of the 3 arms: 3HR (control) (90 doses), 4R (120 doses) or 3HP (12 doses).

Outcome: Proportion of participants who discontinue permanently the assigned treatment. Follow-up: Periodic assessment for permanent or temporary discontinuation, and adverse events of the assigned treatment.

Sample size: 225 subjects (75 per arm) will be needed to demonstrate, if exists, a 0.16 decrease in permanent discontinuation rates in the experimental arms (4R and 3HP) with respect to the control arm (3HR), with α= 0.025, β= 0.20, and 5% expected losses, and assuming a 0.25 proportion of permanent discontinuation in the control.

Conditions

Latent Tuberculosis; Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

3-month Isoniazid plus Rifampicin

Daily isoniazid 300 mg plus rifampicin 600 mg for three months

Group Type: ACTIVE_COMPARATOR

Rifampicin plus Isoniazid

Intervention Type: DRUG

Administration of rifampicin plus isoniazid for latent tuberculosis

3-month Isoniazid plus Rifapentine

Weekly isoniazid 900 mg plus rifapentine 900 mg for 12 weeks

Group Type: EXPERIMENTAL

Rifapentine plus Isoniazid

Intervention Type: DRUG

Administration of rifapentine plus isoniazid for latent tuberculosis

4-month Rifampicin

Daily rifampicin 600 mg for four months

Group Type: EXPERIMENTAL

Rifampicin alone

Intervention Type: DRUG

Administration of rifampicin alone for latent tuberculosis

Interventions

Rifampicin plus Isoniazid

Administration of rifampicin plus isoniazid for latent tuberculosis

Intervention Type: DRUG

Rifapentine plus Isoniazid

Administration of rifapentine plus isoniazid for latent tuberculosis

Intervention Type: DRUG

Rifampicin alone

Administration of rifampicin alone for latent tuberculosis

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigació Biomèdica de Bellvitge

OTHER

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Miguel Santín

OTHER

Sponsor Role: lead

Responsible Party

Miguel Santín

Senior consultant in infectious diseases

Responsibility Role: SPONSOR_INVESTIGATOR

References

Santin M, Perez-Recio S, Grijota MD, Anibarro L, Barcala JM, De Souza-Galvao ML, Gijon P, Luque R, Sanchez F; RIFAKiD team trial. Comparison of three short-course rifamycin-based regimens for the prevention of tuberculosis in patients with end-stage kidney disease: Study protocol for a randomised clinical trial (RIFAKiD-TB trial). PLoS One. 2022 Oct 21;17(10):e0276387. doi: 10.1371/journal.pone.0276387. eCollection 2022.

Reference Type: DERIVED

PMID: 36269714 (View on PubMed)

Other Identifiers

PI21/00444

Identifier Type: -

Identifier Source: org_study_id