Acute Kidney InjuryPhase 4VIBAKINCT04893733
Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients With AKI
A Phase 4 study testing Vitamin B Complex and STOP AKI protocol in people with Acute Kidney Injury, run by Caja Nacional de Salud at 1 site in Bolivia.
Trial summary
Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Vitamin B Complex and STOP AKI protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBolivia
- Study dates
- 1 Sep 2020to 30 Apr 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.
Who cannot join
- Patient under 18 years of age
- Patients with stage G5 chronic kidney disease
- Patients with chronic kidney replacement therapy.
- Pregnant women
- Transplant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury
Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of hospital stay and costs; as well as reducing the incidence of chronic kidney disease (CKD) or progression of CKD after an episode of AKI.
Our main objective is to determine the usefulness of the administration of vitamin B complex as a treatment for established acute kidney injury and its effect on short and long-term outcomes.
- Conditions
- Acute Kidney Injury
- Being tested
- Vitamin B Complex, STOP AKI protocol
- Keywords
- Acute Kidney Injury, Vitamin B complex, Creatinine, Proteinuria
- Medical subject headings
- Acute Kidney Injury, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B ComplexDrug
Also called Complejo B Vimin
Patients with established AKI will be randomized to received IV vitamin B complex each 1 hours for 5 consecutive days versus placebo.
Every patients will also received Institution standard of care for AKI
STOP AKI protocolOther
STOP AKI protocols includes:
S: identify and treat sepsis. Standard measures should be followed to decrease the risk of infection. Close surveillance to identify early signs of infection with appropriate treatment T: avoid nephrotoxins. Avoidance of drugs harmful to the kidneys (e.g. NSAIDs, gentamicin) Care with intravenous iodinated contrast O: optimize blood pressure and optimize volume status. Avoid dehydration e.g. confused patient. Treat hypovolaemia promptly. Consider with-holding patient anti-hypertensives/diuretics until assessed after major surgery or if patient develops sepsis/hypovolemia P: Prevent harm. Identify the cause promptly and manage appropriately to prevent progression. Prevent complications by instituting prompt therapy. Identify drugs excreted through the kidneys and adjust drug doses promptly if AKI develops. Review fluid management plans to prevent inadequate or excessive intravenous fluid administration
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B complex | Experimental | Randomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours. Receives: Drug: Vitamin B Complex; Other: STOP AKI protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete renal recovery
Serum creatinine (CrS) level returns to its baseline value or to a lower value.
Measured: Day 7
Secondary outcomes (3)
Progression to Acute Kidney Disease (AKD)
A eGFR < than 60 ml/m/1.73m2
Measured: 1 month
De novo chronic kidney disease (CKD)
An eGFR < than 60 ml/m/1.73m2
Measured: 3 months
Progression of CKD
Patients progresses from a lower KDIGO CKD stage to a higher CKD stage
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Sep 2020
- Primary completion30 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caja Nacional de Salud
- Sponsor type
- University, hospital or other
- Collaborators
- International Society of Nephrology
- Responsible party
- Principal investigator, Rolando Claure-Del Granado, MD, Caja Nacional de Salud
- Investigators
- Rolando Claure-Del Granado, M.D., Principal investigator, Hospital Obrero No 2 - C.N.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893733
- Sponsor's protocol ID
- VBCNS
- Acronym
- VIBAKI
- Status last verified
- Jul 2022
- First submitted
- 16 May 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04893733
- Acronym / sponsor ID
- VIBAKI / VBCNS
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Vitamin B complex, Creatinine, Proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Caja Nacional de SaludUniversity, hospital or other
- Collaborators
- International Society of Nephrology
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 May 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.
Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of hospital stay and costs; as well as reducing the incidence of chronic kidney disease (CKD) or progression of CKD after an episode of AKI.
Our main objective is to determine the usefulness of the administration of vitamin B complex as a treatment for established acute kidney injury and its effect on short and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin B complex | Experimental | Drug: Vitamin B Complex, Other: STOP AKI protocolRandomized patients with AKI to this arm will received during 5 consecutive days IV Vitamin B complex each 12 hours. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.
Key exclusion criteria (5 listed)
- Patient under 18 years of age
- Patients with stage G5 chronic kidney disease
- Patients with chronic kidney replacement therapy.
- Pregnant women
- Transplant patients
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 |
|---|---|---|
| Vitamin B ComplexAlso: Complejo B ViminPatients with established AKI will be randomized to received IV vitamin B complex each 1 hours for 5 consecutive days versus placebo. Every patients will also received Institution standard of care for AKI | Drug | Vitamin B complex |
| STOP AKI protocolSTOP AKI protocols includes: S: identify and treat sepsis. Standard measures should be followed to decrease the risk of infection. Close surveillance to identify early signs of infection with appropriate treatment T: avoid nephrotoxins. Avoidance of drugs harmful to the kidneys (e.g. NSAIDs, gentamicin) Care with intravenous iodinated contrast O: optimize blood pressure and optimize volume status. Avoid dehydration e.g. confused patient. Treat hypovolaemia promptly. Consider with-holding patient anti-hypertensives/diuretics until assessed after major surgery or if patient develops sepsis/hypovolemia P: Prevent harm. Identify the cause promptly and manage appropriately to prevent progression. Prevent complications by instituting prompt therapy. Identify drugs excreted through the kidneys and adjust drug doses promptly if AKI develops. Review fluid management plans to prevent inadequate or excessive intravenous fluid administration | Other | Vitamin B complex |
Primary outcome
Complete renal recovery
Time frame: Day 7
Serum creatinine (CrS) level returns to its baseline value or to a lower value.
3 secondary outcomes
Progression to Acute Kidney Disease (AKD)
Time frame: 1 month
De novo chronic kidney disease (CKD)
Time frame: 3 months
Progression of CKD
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Rolando Claure-Del Granado, M.D. principal investigator
Hospital Obrero No 2 - C.N.S.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin B Complex and STOP AKI protocol in people with Acute Kidney Injury, run by Caja Nacional de Salud at 1 site in Bolivia.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jan 2025. 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 Bolivia. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete renal recovery (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.