Latent TuberculosisPhase 4NCT05021731
Short-course Rifamycin-based Regimens for Latent Tuberculosis in Patients With End-stage Kidney Disease
A Phase 4 study testing Rifampicin plus Isoniazid, Rifapentine plus Isoniazid and Rifampicin alone in people with Latent Tuberculosis and Kidney Failure, run by Miguel Santín.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Latent Tuberculosis, Kidney Failure
- What is being tested?
- Rifampicin plus Isoniazid, Rifapentine plus Isoniazid and Rifampicin alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Stage 5 kidney disease (glomerular filtrate rate <15 mL/minute or under substitutive renal therapy
- Informed written consent
Who cannot join
- Prior allergy/intolerance to rifamycins or isoniazid
- Pregnancy or breastfeeding
- Pre-treatment transaminases (ALT and/or AST) >5-fold of normality titer
- Concomitant drugs contraindicated with rifamycins
- Having received rifamycins or isoniazid within the two previous weeks
- Weigh <32 Kgs
- Inability to understand the nature of the study or to give written consent
About this study
Official title: Comparison of 3-month Once-weekly Isoniazid Plus Rifapentine, 4-month Daily Rifampicin, and 3-month Daily Isoniazid Plus Rifampicin for the Treatment Latent Tuberculosis in Patients With End-stage Kidney Disease: A Randomised Clinical Trial
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.
Read more
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
- Being tested
- Rifampicin plus Isoniazid, Rifapentine plus Isoniazid, Rifampicin alone
- Keywords
- Tuberculosis, Rifamycins, Rifampicin, Rifapentine, Kidney failure
- Medical subject headings
- Latent Tuberculosis, Renal Insufficiency, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifampicin plus IsoniazidDrug
Administration of rifampicin plus isoniazid for latent tuberculosis
Rifapentine plus IsoniazidDrug
Administration of rifapentine plus isoniazid for latent tuberculosis
Rifampicin aloneDrug
Administration of rifampicin alone for latent tuberculosis
| Study group | Role | What they receive |
|---|---|---|
| 3-month Isoniazid plus Rifampicin | Active comparator | Daily isoniazid 300 mg plus rifampicin 600 mg for three months Receives: Drug: Rifampicin plus Isoniazid |
| 3-month Isoniazid plus Rifapentine | Experimental | Weekly isoniazid 900 mg plus rifapentine 900 mg for 12 weeks Receives: Drug: Rifapentine plus Isoniazid |
| 4-month Rifampicin | Experimental | Daily rifampicin 600 mg for four months Receives: Drug: Rifampicin alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion
Proportion of participants who complete the treatment assigned at randomization, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than in 2 occasions, for 3HR (control arm); 2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for 3HP (experimental arm 1), and 3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than in two occasions, for 4R (experimental arm 2).
Measured: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.
Secondary outcomes (3)
Permanent discontinuation because of adverse events
Proportion of participants who permanently discontinue the treatment assigned, because of adverse events, regardless the relationship of the event/s to the study treatment.
Permanent discontinuation defined as: 1) not completion of 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than in 2 occasions, for 3HR (control arm); 2) not completion 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for 3HP (experimental arm 1), and 3) not completion of 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than in two occasions, for 4R (experimental arm 2).
Measured: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.
Permanent discontinuation because of adverse events related to the treatment
Proportion of participants who permanently discontinue the treatment assigned, because of adverse events related to he study treatment
Permanent discontinuation defined as: 1) not completion of 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than in 2 occasions, for 3HR (control arm); 2) not completion 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for 3HP (experimental arm 1), and 3) not completion of 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than in two occasions, for 4R (experimental arm 2).
Measured: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.
Death
Number of participants who die while on the study, regardless of its relationship to the treatment assigned at randomization
Measured: From date of randomization until four weeks after completing the assigned treatment, or lost to follow-up, assessed up to 17 weeks for the 3HR arm, 15 weeks for the 3HP arm, and 21 weeks for the 4R arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start20 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miguel Santín
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Miguel Santín, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021731
- Sponsor's protocol ID
- PI21/00444
- Status last verified
- Mar 2024
- First submitted
- 13 Aug 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36269714
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3-month Once-weekly Isoniazid Plus Rifapentine, 4-month Daily Rifampicin, and 3-month Daily Isoniazid Plus Rifampicin for the Treatment Latent Tuberculosis in Patients With End-stage Kidney Disease: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05021731
- Acronym / sponsor ID
- PI21/00444
- Conditions
- Latent Tuberculosis, Kidney Failure
- Keywords
- Tuberculosis, Rifamycins, Rifampicin, Rifapentine, Kidney failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Miguel SantínUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Instituto de Salud Carlos III
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-month Isoniazid plus Rifampicin | Active comparator | Drug: Rifampicin plus IsoniazidDaily isoniazid 300 mg plus rifampicin 600 mg for three months |
| 3-month Isoniazid plus Rifapentine | Experimental | Drug: Rifapentine plus IsoniazidWeekly isoniazid 900 mg plus rifapentine 900 mg for 12 weeks |
| 4-month Rifampicin | Experimental | Drug: Rifampicin aloneDaily rifampicin 600 mg for four months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Stage 5 kidney disease (glomerular filtrate rate <15 mL/minute or under substitutive renal therapy
- Informed written consent
Key exclusion criteria (7 listed)
- Prior allergy/intolerance to rifamycins or isoniazid
- Pregnancy or breastfeeding
- Pre-treatment transaminases (ALT and/or AST) >5-fold of normality titer
- Concomitant drugs contraindicated with rifamycins
- Having received rifamycins or isoniazid within the two previous weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampicin plus IsoniazidAdministration of rifampicin plus isoniazid for latent tuberculosis | Drug | 3-month Isoniazid plus Rifampicin |
| Rifapentine plus IsoniazidAdministration of rifapentine plus isoniazid for latent tuberculosis | Drug | 3-month Isoniazid plus Rifapentine |
| Rifampicin aloneAdministration of rifampicin alone for latent tuberculosis | Drug | 4-month Rifampicin |
Primary outcome
Treatment completion
Time frame: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.
Proportion of participants who complete the treatment assigned at randomization, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than in 2 occasions, for 3HR (control arm); 2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for 3HP (experimental arm 1), and 3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than in two occasions, for 4R (experimental arm 2).
3 secondary outcomes
Permanent discontinuation because of adverse events
Time frame: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.
Permanent discontinuation because of adverse events related to the treatment
Time frame: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.
Death
Time frame: From date of randomization until four weeks after completing the assigned treatment, or lost to follow-up, assessed up to 17 weeks for the 3HR arm, 15 weeks for the 3HP arm, and 21 weeks for the 4R arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 36269714Santin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifampicin plus Isoniazid, Rifapentine plus Isoniazid and Rifampicin alone in people with Latent Tuberculosis and Kidney Failure, run by Miguel Santín.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment completion (time frame: From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05021731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.