Acute Kidney InjuryCRRTNCT07514650
Validation of a Regional Citrate Anticoagulation Protocol in Critically Ill Patients on Continuous Renal Replacement Therapy
A study testing continuous renal replacement therapy in people with Acute Kidney Injury and ICU Patients, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the effectiveness of a modified continuous renal replacement therapy (CRRT) protocol in maintaining electrolyte balance in adult patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, ICU Patients, Continuous Renal Replacement Therapy (CRRT)
- What is being tested?
- continuous renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Admission to the intensive care unit (ICU)
- Diagnosis of acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT)
- Use of regional citrate anticoagulation during CRRT Exclusion Criteria
- Known allergy or intolerance to citrate
- Contraindications to citrate anticoagulation (e.g., severe liver failure or severe metabolic disorders affecting citrate metabolism)
- Pregnancy or breastfeeding
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alejandra Espinosa Guerrero, Clinical Operations Head contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Ana Jiménez Valenzuela, Nurse, +34662172345, ajimenezva@santpau.cat
Alejandra Espinosa, Clinical Operations Head, +34935537796 ext. 7796, uicec@santpau.cat
About this study
The objective of this study is to evaluate the effectiveness of a modified continuous renal replacement therapy (CRRT) protocol in maintaining electrolyte balance in adult patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU).
The study assesses whether the use of continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under citrate anticoagulation reduces electrolyte losses and the need for electrolyte supplementation compared with standard dialytic CRRT.
Read more
Participants receiving standard CRRT will be compared with those treated with the modified protocol.
The duration of participation corresponds to the period during which CRRT is required. Data collection will cease once CRRT is discontinued.
Read the detailed description
Electrolyte disturbances are common in patients undergoing continuous renal replacement therapy (CRRT) with regional citrate anticoagulation due to significant electrolyte losses during treatment. These alterations may lead to clinically relevant complications and increased need for electrolyte supplementation.
This study evaluates a modified CRRT protocol combining diffusive and convective modalities with post-filter replacement, aiming to improve electrolyte balance and reduce electrolyte supplementation requirements.
The primary objective is to assess whether continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement reduces the need for electrolyte supplementation compared with standard continuous venovenous hemodialysis (CVVHD) in patients with acute kidney injury.
This is a non-randomized interventional study with sequential assignment comparing a prospective cohort treated with the modified CRRT protocol and a historical control cohort treated with standard dialytic CRRT.
The study population includes adult patients (≥18 years) admitted to the multidisciplinary ICU of Hospital de la Santa Creu i Sant Pau with a diagnosis of acute kidney injury requiring CRRT.
- Conditions
- Acute Kidney Injury, ICU Patients, Continuous Renal Replacement Therapy (CRRT), Electrolytes
- Being tested
- continuous renal replacement therapy
- Keywords
- Regional Citrate Anticoagulation, Acute Kidney Injury, ICU patients, Continuous Renal Replacement Therapy, Diluted citrate, Electrolytes
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous renal replacement therapyProcedure or surgery
Also called CVVHDF, CVVHD
Continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Treatment modalities include continuous venovenous hemodialysis (CVVHD) and continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement, depending on study group assignment.
| Study group | Role | What they receive |
|---|---|---|
| CVVHD (Historical Control) | Active comparator | Historical control cohort of patients treated with continuous venovenous hemodialysis (CVVHD) with regional citrate anticoagulation between 2019 and 2021 in the intensive care unit (ICU) of Hospital de la Santa Creu i Sant Pau. Receives: Procedure: continuous renal replacement therapy |
| CVVHDF with Post-Filter Replacement | Experimental | Prospective cohort of patients treated with continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under regional citrate anticoagulation. Patients admitted to the ICU of Hospital de la Santa Creu i Sant Pau from November 2024 onwards who require continuous renal replacement therapy (CRRT) will be included. Receives: Procedure: continuous renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total electrolyte supplementation during CRRT
Total amount of electrolyte supplementation administered during continuous renal replacement therapy (CRRT), including potassium, magnesium, and phosphate, expressed as total mmol administered per day (mmol/day)
Measured: From CRRT initiation through CRRT discontinuation, up to 14 days
Secondary outcomes (1)
CRRT circuit lifespan (hours)
Duration of each CRRT circuit, defined as the total time in hours that the extracorporeal circuit remains functional before replacement.
Measured: Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start24 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a non-randomized interventional study with sequential assignment comparing a prospective cohort treated with a modified CRRT protocol including post-filter replacement with a historical control cohort treated with standard dialytic CRRT.
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Jiménez Valenzuela, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Alejandra Espinosa Guerrero, Clinical Operations Head, Study director, Fundació de Gestió Sanitarària de l'Hospital de la Santa Creu i Sant Pau de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514650
- Sponsor's protocol ID
- IIBSP-CIT-2024-81
- Acronym
- CRRT
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and the sensitive nature of patient data.
Publications
Morabito S, Pistolesi V, Tritapepe L, Vitaliano E, Zeppilli L, Polistena F, Fiaccadori E, Pierucci A. Continuous venovenous hemodiafiltration with a low citrate dose regional anticoagulation protocol and a phosphate-containing solution: effects on acid-base status and phosphate supplementation needs. BMC Nephrol. 2013 Oct 25;14:232. doi: 10.1186/1471-2369-14-232.
PubMed 24156306Di Mario F, Regolisti G, Greco P, Maccari C, Superchi E, Morabito S, Pistolesi V, Fiaccadori E. Prevention of hypomagnesemia in critically ill patients with acute kidney injury on continuous kidney replacement therapy: the role of early supplementation and close monitoring. J Nephrol. 2021 Aug;34(4):1271-1279. doi: 10.1007/s40620-020-00864-4. Epub 2020 Oct 1.
PubMed 33001413Jacobs R, Verbrugghe W, Dams K, Roelant E, Couttenye MM, Devroey D, Jorens P. Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Life (Basel). 2023 May 17;13(5):1198. doi: 10.3390/life13051198.
PubMed 37240843Datzmann T, Trager K, Reinelt H, von Freyberg P. Elimination Rates of Electrolytes, Vitamins, and Trace Elements during Continuous Renal Replacement Therapy with Citrate Continuous Veno-Venous Hemodialysis: Influence of Filter Lifetime. Blood Purif. 2017;44(3):210-216. doi: 10.1159/000477454. Epub 2017 Aug 9.
PubMed 28787723Jeffrey YH, Hoi-Ping S, Kit Hung AL, Chung-Ling L, Wing-Wa Y, King-Yiu L. Experiences with Continuous Venovenous Hemofiltration using 18mmol/L predilution Citrate anticoagulation and a Phosphate Containing Replacement Solution. Indian J Crit Care Med. 2017 Jan;21(1):11-16. doi: 10.4103/0972-5229.198311.
PubMed 28197045Morabito S, Pistolesi V, Tritapepe L, Zeppilli L, Polistena F, Fiaccadori E, Pierucci A. Regional citrate anticoagulation in CVVH: a new protocol combining citrate solution with a phosphate-containing replacement fluid. Hemodial Int. 2013 Apr;17(2):313-20. doi: 10.1111/j.1542-4758.2012.00730.x. Epub 2012 Aug 7.
PubMed 22882732Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618.
PubMed 33095849Gould DW, Doidge J, Sadique MZ, Borthwick M, Hatch R, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Ostermann M, Mouncey PR, Harrison DA, Rowan KM, Young JD, Watkinson PJ. Heparin versus citrate anticoagulation for continuous renal replacement therapy in intensive care: the RRAM observational study. Health Technol Assess. 2022 Feb;26(13):1-58. doi: 10.3310/ZXHI9396.
PubMed 35212260Mateos-Davila A, Betbese Roig AJ, Santos Rodriguez JA, Guix-Comellas EM. Comparison of diluted vs concentrated regional citrate anticoagulation in continuous renal replacement therapy: A quasi-experimental study. Nurs Crit Care. 2024 Sep;29(5):1005-1014. doi: 10.1111/nicc.12991. Epub 2023 Oct 27.
PubMed 37897131
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Regional Citrate Anticoagulation Protocol in Critically Ill Patients on Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT07514650
- Acronym / sponsor ID
- CRRT / IIBSP-CIT-2024-81
- Conditions
- Acute Kidney Injury, ICU Patients, Continuous Renal Replacement Therapy (CRRT), Electrolytes
- Keywords
- Regional Citrate Anticoagulation, Acute Kidney Injury, ICU patients, Continuous Renal Replacement Therapy, Diluted citrate, Electrolytes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
The objective of this study is to evaluate the effectiveness of a modified continuous renal replacement therapy (CRRT) protocol in maintaining electrolyte balance in adult patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU).
The study assesses whether the use of continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under citrate anticoagulation reduces electrolyte losses and the need for electrolyte supplementation compared with standard dialytic CRRT.
Participants receiving standard CRRT will be compared with those treated with the modified protocol.
The duration of participation corresponds to the period during which CRRT is required. Data collection will cease once CRRT is discontinued.
Detailed description
Electrolyte disturbances are common in patients undergoing continuous renal replacement therapy (CRRT) with regional citrate anticoagulation due to significant electrolyte losses during treatment. These alterations may lead to clinically relevant complications and increased need for electrolyte supplementation.
This study evaluates a modified CRRT protocol combining diffusive and convective modalities with post-filter replacement, aiming to improve electrolyte balance and reduce electrolyte supplementation requirements.
The primary objective is to assess whether continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement reduces the need for electrolyte supplementation compared with standard continuous venovenous hemodialysis (CVVHD) in patients with acute kidney injury.
This is a non-randomized interventional study with sequential assignment comparing a prospective cohort treated with the modified CRRT protocol and a historical control cohort treated with standard dialytic CRRT.
The study population includes adult patients (≥18 years) admitted to the multidisciplinary ICU of Hospital de la Santa Creu i Sant Pau with a diagnosis of acute kidney injury requiring CRRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized interventional study with sequential assignment comparing a prospective cohort treated with a modified CRRT protocol including post-filter replacement with a historical control cohort treated with standard dialytic CRRT.
| Arm | Type | Receives |
|---|---|---|
| CVVHD (Historical Control) | Active comparator | Procedure: continuous renal replacement therapyHistorical control cohort of patients treated with continuous venovenous hemodialysis (CVVHD) with regional citrate anticoagulation between 2019 and 2021 in the intensive care unit (ICU) of Hospital de la Santa Creu i Sant Pau. |
| CVVHDF with Post-Filter Replacement | Experimental | Procedure: continuous renal replacement therapyProspective cohort of patients treated with continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under regional citrate anticoagulation. Patients admitted to the ICU of Hospital de la Santa Creu i Sant Pau from November 2024 onwards who require continuous renal replacement therapy (CRRT) will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Admission to the intensive care unit (ICU)
- Diagnosis of acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT)
- Use of regional citrate anticoagulation during CRRT Exclusion Criteria
- Known allergy or intolerance to citrate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| continuous renal replacement therapyAlso: CVVHDF, CVVHDContinuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Treatment modalities include continuous venovenous hemodialysis (CVVHD) and continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement, depending on study group assignment. | Procedure or surgery | CVVHD (Historical Control), CVVHDF with Post-Filter Replacement |
Primary outcome
Total electrolyte supplementation during CRRT
Time frame: From CRRT initiation through CRRT discontinuation, up to 14 days
Total amount of electrolyte supplementation administered during continuous renal replacement therapy (CRRT), including potassium, magnesium, and phosphate, expressed as total mmol administered per day (mmol/day)
1 secondary outcome
CRRT circuit lifespan (hours)
Time frame: Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 24156306Morabito S, Pistolesi V, Tritapepe L, Vitaliano E, Zeppilli L, Polistena F, Fiaccadori E, Pierucci A. Continuous venovenous hemodiafiltration with a low citrate dose regional anticoagulation protocol and a phosphate-containing solution: effects on acid-base status and phosphate supplementation needs. BMC Nephrol. 2013 Oct 25;14:232. doi: 10.1186/1471-2369-14-232.
- Background: PubMed 33001413Di Mario F, Regolisti G, Greco P, Maccari C, Superchi E, Morabito S, Pistolesi V, Fiaccadori E. Prevention of hypomagnesemia in critically ill patients with acute kidney injury on continuous kidney replacement therapy: the role of early supplementation and close monitoring. J Nephrol. 2021 Aug;34(4):1271-1279. doi: 10.1007/s40620-020-00864-4. Epub 2020 Oct 1.
- Background: PubMed 37240843Jacobs R, Verbrugghe W, Dams K, Roelant E, Couttenye MM, Devroey D, Jorens P. Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Life (Basel). 2023 May 17;13(5):1198. doi: 10.3390/life13051198.
- Background: PubMed 28787723Datzmann T, Trager K, Reinelt H, von Freyberg P. Elimination Rates of Electrolytes, Vitamins, and Trace Elements during Continuous Renal Replacement Therapy with Citrate Continuous Veno-Venous Hemodialysis: Influence of Filter Lifetime. Blood Purif. 2017;44(3):210-216. doi: 10.1159/000477454. Epub 2017 Aug 9.
- Background: PubMed 28197045Jeffrey YH, Hoi-Ping S, Kit Hung AL, Chung-Ling L, Wing-Wa Y, King-Yiu L. Experiences with Continuous Venovenous Hemofiltration using 18mmol/L predilution Citrate anticoagulation and a Phosphate Containing Replacement Solution. Indian J Crit Care Med. 2017 Jan;21(1):11-16. doi: 10.4103/0972-5229.198311.
- Background: PubMed 22882732Morabito S, Pistolesi V, Tritapepe L, Zeppilli L, Polistena F, Fiaccadori E, Pierucci A. Regional citrate anticoagulation in CVVH: a new protocol combining citrate solution with a phosphate-containing replacement fluid. Hemodial Int. 2013 Apr;17(2):313-20. doi: 10.1111/j.1542-4758.2012.00730.x. Epub 2012 Aug 7.
- Background: PubMed 33095849Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618.
- Background: PubMed 35212260Gould DW, Doidge J, Sadique MZ, Borthwick M, Hatch R, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Ostermann M, Mouncey PR, Harrison DA, Rowan KM, Young JD, Watkinson PJ. Heparin versus citrate anticoagulation for continuous renal replacement therapy in intensive care: the RRAM observational study. Health Technol Assess. 2022 Feb;26(13):1-58. doi: 10.3310/ZXHI9396.
- Background: PubMed 37897131Mateos-Davila A, Betbese Roig AJ, Santos Rodriguez JA, Guix-Comellas EM. Comparison of diluted vs concentrated regional citrate anticoagulation in continuous renal replacement therapy: A quasi-experimental study. Nurs Crit Care. 2024 Sep;29(5):1005-1014. doi: 10.1111/nicc.12991. Epub 2023 Oct 27.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and the sensitive nature of patient data.
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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.
Alejandra Espinosa Guerrero, Clinical Operations Head contact
Alejandra Espinosa Guerrero, Clinical Operations Head study director
Fundació de Gestió Sanitarària de l'Hospital de la Santa Creu i Sant Pau de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous renal replacement therapy in people with Acute Kidney Injury and ICU Patients, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 7 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Jiménez Valenzuela, Nurse (+34935537796, ajimenezva@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total electrolyte supplementation during CRRT (time frame: From CRRT initiation through CRRT discontinuation, up to 14 days). 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 NCT07514650, which also lists 9 linked publications.
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 7 Apr 2026.