What is the mechanism of action of this treatment?

Isoniazid works by inhibiting the synthesis of mycolic acids, essential components of the mycobacterial cell wall, thereby killing the bacteria. Rifapentine inhibits bacterial RNA polymerase, preventing the bacteria from synthesizing RNA and proteins, which is crucial for their survival and replication. Vitamin B6 (pyridoxine) is included to prevent peripheral neuropathy, a common side effect of Isoniazid. These mechanisms are vital for Latent Tuberculosis patients as they target the bacteria in its dormant state, reducing the risk of reactivation and progression to active tuberculosis, which is more difficult to treat and can be contagious.

What side effects are associated with this type of intervention?

The most common treatments for Latent Tuberculosis, such as Isoniazid, Rifapentine, and Vitamin B6, have specific side effects. Isoniazid can cause hepatotoxicity and peripheral neuropathy, while Rifapentine may lead to hepatotoxicity, gastrointestinal upset, and hypersensitivity reactions. Vitamin B6 is used to prevent Isoniazid-induced peripheral neuropathy and is generally well-tolerated. Combining these medications can increase the risk of liver toxicity, necessitating regular liver function monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for latent tuberculosis infection (LTBI), including regimens involving Isoniazid and Rifapentine. Isoniazid, which inhibits mycolic acid synthesis, has been a cornerstone of LTBI treatment for decades. Rifapentine, which inhibits bacterial RNA polymerase, is often used in combination with Isoniazid for shorter, more effective treatment courses. Vitamin B6 (pyridoxine) is commonly co-administered with Isoniazid to prevent peripheral neuropathy, a known side effect of Isoniazid. These drugs are part of the standard treatment regimens recommended for LTBI to prevent the progression to active tuberculosis.

What other types of research exist?

Promising novel alternatives for Latent Tuberculosis treatment in 2024 include fluoroquinolones (e.g., levofloxacin, moxifloxacin), bedaquiline, and delamanid. These drugs offer different mechanisms of action and have shown efficacy in treating mycobacterial infections.

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Antibiotic

1-Month TB Therapy for Kidney Transplant Candidates

Phase 4

Recruiting

Led By Pinki Bhatt, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight > 30 kg

End-stage renal disease

Must not have

Prior history of treatment for active TB or LTBI

Known history of or active porphyria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a treatment with two antibiotics and a vitamin for kidney transplant candidates who have latent TB. The goal is to see if this shorter treatment is safe, effective, and easier for patients to complete compared to the longer standard treatment.

Who is the study for?

This trial is for adults over 18 with end-stage kidney disease who are candidates for a kidney transplant, weigh more than 30 kg, and have latent tuberculosis or a high risk of developing it. They must not be on the waitlist yet but approved by their nephrologist. Pregnant women and individuals with certain medical conditions or drug dependencies that could affect treatment adherence are excluded.

What is being tested?

The study tests a one-month regimen combining Rifapentine, Isoniazid, and Vitamin B6 in renal transplant candidates to assess safety, compliance, and how the body processes these drugs. It's an open-label study where all participants receive the same treatment without any comparison group.

What are the potential side effects?

Potential side effects may include liver issues (hepatotoxicity), nerve damage (neuropathy), allergic reactions to medications, blood disorders like low neutrophil count or platelets, digestive problems due to medication interactions, and possibly increased bilirubin levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh more than 30 kilograms.

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My kidneys are in the final stage of failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated for TB in the past.

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I have a history of or currently have porphyria.

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I have a history of liver cirrhosis.

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I have active tuberculosis.

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I am not on medications that badly interact with Rifapentine or INH.

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I am taking medication that can affect my liver or lower my white blood cells.

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I have been exposed to TB that is resistant to multiple drugs.

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My nerve damage does not severely affect my daily activities.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Rate of treatment completion

Rate of treatment compliance

Other study objectives

3-hour post-dose drug concentration

Rate of reactivation of active tuberculosis

Trough drug concentration

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1 month Rifapentine, Isoniazid and Vitamin B6Experimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Isoniazid works by inhibiting the synthesis of mycolic acids, essential components of the mycobacterial cell wall, thereby killing the bacteria. Rifapentine inhibits bacterial RNA polymerase, preventing the bacteria from synthesizing RNA and proteins, which is crucial for their survival and replication. Vitamin B6 (pyridoxine) is included to prevent peripheral neuropathy, a common side effect of Isoniazid. These mechanisms are vital for Latent Tuberculosis patients as they target the bacteria in its dormant state, reducing the risk of reactivation and progression to active tuberculosis, which is more difficult to treat and can be contagious.