Status:
RECRUITING
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Latent Tuberculosis
End Stage Renal Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 tran...
Detailed Description
Latent tuberculosis infection (LTBI) or inactive tuberculosis, is a common disease found in patients with end-stage renal disease (ESRD) who are being considered for renal transplant (RT). Approximate...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- On medications known to cause hepatoxicity and/or neutropenia
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05411744
Start Date
July 1 2022
End Date
June 30 2029
Last Update
March 10 2025
Active Locations (1)
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1
Pinki J Bhatt
New Brunswick, New Jersey, United States, 08901