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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05960227




Registration number
NCT05960227
Ethics application status
Date submitted
19/09/2022
Date registered
25/07/2023

Titles & IDs
Public title
Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury
Scientific title
Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury, Clinical Trial
Secondary ID [1] 0 0
HCG
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia, Iron Deficiency 0 0
Acute Kidney Injury 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Blood 0 0 0 0
Anaemia
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Iron dextran
Treatment: Drugs - Placebo

Experimental: Iron dextran IV - In patients with acute renal damage, they will be aleatorized to receive the administration of intravenous iron dextran 1200mg in 1 single exhibition compared to placebo.

Placebo comparator: Placebo - In patients with acute renal damage, they will be aleatorized to receive the administration of placebo.


Treatment: Drugs: Iron dextran
Administration of 1.2g of iron dextran in infusion bolus as a loading strategy.

Treatment: Drugs: Placebo
250ml of saline 0,9% for 4 hours insusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Renal function estimated in GFR at 3 months of randomization. Which will be evaluated by the estimation of the GFR by the equation CKD-EPI by serum creatinine.
Timepoint [1] 0 0
3 months of randomization
Secondary outcome [1] 0 0
All of the following will be at hospital discharge and 28 days after hospital discharge between the intervention group (iron replacement) compared to the control group (placebo).
Timepoint [1] 0 0
28 days of discharge from hospital between iron dextran group and placebo group
Secondary outcome [2] 0 0
Need of renal replacement therapy
Timepoint [2] 0 0
28 days of discharge from hospital between iron dextran group and placebo group

Eligibility
Key inclusion criteria
* Hospitalized patients with acute kidney injury
* iron levels <13 µmol/L or a transferrin saturation <20%
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* AKI within the past three months
* less than 18 years old
* Chronic Kidney Disease grade 5
* chronic dialysis
* kidney transplant
* hospital stay less tahn 48 hours
* received any red blood cell transfusion before randomization
* missing data that would render analysis incomplete.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2024
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Jalisco

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital Civil de Guadalajara
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05960227