Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
225
Countries
1
Sites
7
Latent tuberculosis infection in patients with end-stage kidney disease.
To determine if treatment completion with three months of once-weekly isoniazid plus rifapentine (3HP) or four months of daily rifampicin (4R) is better compared with three months of daily isoniazid plus rifampicin (3HR) for treatment of latent tuberculosis infection in patients with endstage kidney disease.
Key facts
- Sponsor
- Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 11 Apr 2024 → 23 Mar 2026
- Decision date (initial)
- 2023-11-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Others, Safety
To determine if treatment completion with three months of once-weekly isoniazid plus rifapentine (3HP) or four months of daily rifampicin (4R) is better compared with three months of daily isoniazid plus rifampicin (3HR) for treatment of latent tuberculosis infection in patients with endstage kidney disease.
Secondary objectives 1
- To determine the safety and tolerability of a 3HR, 3HP, and 4R regimens for the treatment of latent TB infection in patients with end-stage kidney disease.
Conditions and MedDRA coding
Latent tuberculosis infection in patients with end-stage kidney disease.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Patients 18 years or older with kidney disease stage ≥ 4 (glomerular filtrate rate ≤29 mL/minute or under substitutive renal therapy) who require treatment for latent tuberculosis infection.
- 2. Female with negative pregnancy test prior to enrolment.
- 3. Female of childbearing age willing to take appropriate barrier contraceptive measures.
- 4. Informed written consent.
Exclusion criteria 7
- 1. Prior allergy/intolerance to rifamycins or isoniazid.
- 2. Pregnancy or breastfeeding.
- 3. Pre-treatment transaminases (ALT and/or AST) >5-fold of the upper limit of the normality titer.
- 4. Concomitant treatment with drugs contraindicated with the study medications.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- The primary endpoint will be the proportion of participants who complete the assigned treatment regimen, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than on 2 occasions, for the 3HR arm (control)
- 2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for the 3HP arm (experimental 1)
- 3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than on two occasions, for the 4R arm (experimental 2).
Secondary endpoints 3
- 1. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, regardless of its relationship to the treatment of the study 2. Proportion of participants.
- 2. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, related to the treatment of the study.
- 3. Crude mortality: Number of participants who die while on the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB10311MIG · Substance
- Active substance
- Rifapentine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/750
- Modified vs. Marketing Authorisation
- No
PRD318182 · Product
- Active substance
- Isoniazid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J04AC51 — ISONIAZID, COMBINATIONS
- Marketing authorisation
- 63335
- MA holder
- CHIESI ESPAÑA S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rimactán 300 mg cápsulas duras
PRD800530 · Product
- Active substance
- Rifampicin
- Substance synonyms
- RIFAMPIN
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J04AB02 — RIFAMPICIN
- Marketing authorisation
- 49.034
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD421291 · Product
- Active substance
- Rifampicin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- J04AB02 — RIFAMPICIN
- Marketing authorisation
- 46029
- MA holder
- MARION MERRELL S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bellvitge University Hospital
- Sponsor organisation
- Bellvitge University Hospital
- Address
- Carrer De La Feixa Llarga Sn
- City
- L'hospitalet De Llobregat
- Postcode
- 08907
- Country
- Spain
Scientific contact point
- Organisation
- Bellvitge University Hospital
- Contact name
- Miguel Santin
Public contact point
- Organisation
- Bellvitge University Hospital
- Contact name
- Miguel Santin
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Alba Pharmaceuticals S.L. ORG-100013748
|
Benicarlo, Spain | Other |
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
- Sponsor organisation
- Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
- Address
- Avinguda De La Gran Via De L'hospitalet 199
- City
- L'Hospitalet De Llobregat
- Postcode
- 08908
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
- Contact name
- Yaiza Hermoso Gallego
Public contact point
- Organisation
- Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
- Contact name
- Yaiza Hermoso Gallego
Sponsor responsibilities
- Article 77 compliance
- Bellvitge University Hospital
- Contact point sponsor
- Bellvitge University Hospital
- Article 77 implementation
- Bellvitge University Hospital
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 225 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital General Universitario Gregorio Maranon
Service of Clinical Microbiology and Infectious Diseases, Calle Del Doctor Esquerdo 46, 28009, Madrid
University Hospital Virgen Del Rocio S.L.
Service of Infectious Diseases, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Del Mar
Tuberculosis Unit, Service of Infectious Diseases, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Complexo Hospitalario Universitario De Pontevedra
Infectious Diseases Unit, Service of Internal Medicine, Calle Mourente S/n, 36164, Pontevedra
Bellvitge University Hospital
Tuberculosis Unit, Service of Infectious Diseases, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Tuberculosis Unit, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Son Espases
Internal medicine, Carretera Valldemossa 79, 07120, Palma
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-04-11 | 2026-03-23 | 2024-04-19 | 2025-10-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo 2023-506432-32_cc | 4.0 |
| Protocol (for publication) | D1_Protocolo 2023-506432-32_Final | 4.0 |
| Protocol (for publication) | D1_Scheduled assessment visits 2023-506432-32_cc | 4.0 |
| Protocol (for publication) | D1_Scheduled assessment visits 2023-506432-32_Final | 4.0 |
| Protocol (for publication) | D2_Protocolo modification number 2 2023-506432-32_cc | 5.0 |
| Protocol (for publication) | D2_Protocolo modification number 2 2023-506432-32_final | 5.0 |
| Protocol (for publication) | Protocolo_2023-506432-32 | 3.0 |
| Protocol (for publication) | Scheduled assessment visits 2023-506432-32 | 2.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | ICF_2023-506432-32 | 4.0 |
| Subject information and informed consent form (for publication) | ICF_Data_Protection 2023-506432-32 | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Cemidon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Priftin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Rifaldin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Rimactan | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis_ESP_2023-506432-32 | 2.0 |
| Synopsis of the protocol (for publication) | Protocol Synopsis_ESP_2023-506432-32 | 3.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-05 | Spain | Acceptable 2023-11-28
|
2023-11-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-18 | Spain | Acceptable 2025-01-20
|
2025-01-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-04 | Spain | Acceptable 2026-04-20
|
2026-04-22 |