Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury

September 30, 2024 updated by: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara

Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury, Clinical Trial

This clinical trial aims to carry out research on the effect on hemoglobin and renal function of intravenous administration of iron dextran as a repletion strategy in patients with iron deficiency anemia and acute kidney injury, in which the patient may benefit from this drug as it is expected to correct anemia, ferropenia and renal function parameters, when compared with a control group (placebo), the safety of the drug will also be assessed by recording adverse effects.

The investigators will point out with the patient the risks and benefits of their inclusion in this type of study and the investigators will attend to all the doubts that are generated, as well as immediately report to the research ethics committee any serious adverse effects. The results will be presented at national and international conferences and will be published in high-impact journals, and will also be the subject of a thesis to achieve the title of specialist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury is a complication that occurs in up to 30% of hospitalized patients, iron deficiency has a high incidence in the critically ill patient population and has been associated with multiple complications such as the development of anemia and renal dysfunction. The presence of iron deficiency, anemia and acute kidney damage is a common combination in critically ill patients and it has been seen that iron deficiency promotes mitochondrial dysfunction and this can be improved with the correction of intravenous iron, as has happened in clinical trials of patients with acute heart failure, improving their clinical evolution.

There is insufficient evidence for the implementation of intravenous iron with the aim of improving the parameters of iron deficiency anaemia in patients with acute kidney injury.

To the knowledge of the investigators, there is no clinical trial that has explored this outcomes.

Primary objective:

• Renal function estimated in GFR at 3 months after randomization. Which will be evaluated by the estimation of the GFR by the equation CKD-EPI by serum creatinine

Secondary objectives: 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).

  • ferritin value, (pg/dL)
  • transferrin saturation (%)
  • Hemoglobin (g/dL)
  • serum creatinine (mg/dL)
  • initiation of renal support therapy (any type of renal support such as: intermittent haemodialysis, peritoneal dialysis or continuous therapies)
  • recovery of renal function, seen as decreased serum creatinine and approaching <0.3mg/dL of baseline creatinine
  • death

Exploratory objectives:

• safety of intravenous iron administration compared to placebo: assessed for the occurrence of adverse events such as allergic reaction, hypotension, dyspnea, rash, erythema. These will be evaluated during the administration of the drug and during hospitalization frequently every 24 hours by the nephrology staff that includes the study researchers.

Our hypothesis is that intravenous iron dextran repletion during the treatment of acute kidney injury will improve the parameters of renal function, iron deficiency, anemia and also that it will be safe compared to placebo.

STUDY DESIGN Randomized, placebo-controlled clinical trial, method of randomization in blocks of 5 by frequency of occurrence. In patients with acute renal injury, they will be aleatorized to receive the administration of intravenous iron dextran in 1 single exhibition according to the Mg granted by the Virizzi formula compared to placebo.

The sample size determined 55 patients per group, with a standard deviation of 1.5.

The randomization process was carried out with the NCI Clinical Trial Randomization Tool:

https://ctrandomization.cancer.gov/

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44240
        • Hospital Civil de Guadalajara
      • Guadalajara, Jalisco, Mexico, 44280
        • Jonathan Samuel Chávez Iñiguez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized patients with acute kidney injury
  • iron levels <13 μmol/L or a transferrin saturation <20%

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Iron dextran
Administration of 1.2g of iron dextran in infusion bolus as a loading strategy.
Placebo Comparator: Placebo
In patients with acute renal damage, they will be aleatorized to receive the administration of placebo.
Drug: Placebo
250ml of saline 0,9% for 4 hours insusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months of randomization
The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation was developed in an effort to create a more precise formula to estimate glomerular filtrate rate (GFR) from serum creatinine and other readily available clinical parameters, especially at when actual GFR is >60 mL/min per 1.73m2.
3 months of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 28 days of discharge from hospital between iron dextran group and placebo group
Ferritin value, (pg/dL)
28 days of discharge from hospital between iron dextran group and placebo group
Need of renal replacement therapy
Time Frame: 28 days of discharge from hospital between iron dextran group and placebo group
Number of Participants with initiation of renal replacement therapy (any type of renal support such as: intermittent haemodialysis, peritoneal dialysis or continuous therapies)
28 days of discharge from hospital between iron dextran group and placebo group

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of intravenous iron
Time Frame: 1 day
Number of Participants with adverse events such as allergic reaction, hypotension, dyspnea, rash, erythema. These will be evaluated during the administration of the drug and during hospitalization frequently every 24 hours by the nephrology staff that includes the study researchers.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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