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

Sponsor

Hospital Civil de Guadalajara (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05960227

Collaborator

(none)

Enrollment

Locations

Arms

8.8

Anticipated Duration (Months)

27.5

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia, Iron Deficiency Acute Kidney Injury	Drug: Iron dextran Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 6, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

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). [28 days of discharge from hospital between iron dextran group and placebo group]
Ferritin value, (pg/dL)
Need of renal replacement therapy [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)

Other Outcome Measures

safety of intravenous iron [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.