Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05960227 |
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Recruitment Status :
Active, not recruiting
First Posted : July 25, 2023
Last Update Posted : July 25, 2023
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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 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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. |
| 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 : | January 6, 2023 |
| Estimated Primary Completion Date : | September 30, 2023 |
| Estimated Study Completion Date : | September 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Iron dextran
Administration of 1.2g of iron dextran in infusion bolus as a loading strategy. |
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Placebo Comparator: Placebo
In patients with acute renal damage, they will be aleatorized to receive the administration of placebo.
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Drug: Placebo
250ml of saline 0,9% for 4 hours insusion. |
- 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.
- 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)
- 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)
- 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.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hospitalized patients with acute kidney injury
- Anemia <13g/L in men and <12.5g/l in women
- Ferropenia <500ng/dl
- Transferrin saturation < 30%
Exclusion Criteria:
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05960227
| Mexico | |
| Hospital Civil de Guadalajara | |
| Guadalajara, Jalisco, Mexico, 44240 | |
| Jonathan Samuel Chávez Iñiguez | |
| Guadalajara, Jalisco, Mexico, 44280 | |
Documents provided by Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara:
| Responsible Party: | Jonathan Samuel Chavez Iñiguez, Head of nephrology Jonathan Samuel Chavez Iñiguez MD., Hospital Civil de Guadalajara |
| ClinicalTrials.gov Identifier: | NCT05960227 |
| Other Study ID Numbers: |
HCG |
| First Posted: | July 25, 2023 Key Record Dates |
| Last Update Posted: | July 25, 2023 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Acute kidney injury Anemia Iron deficiency |
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Acute Kidney Injury Anemia, Iron-Deficiency Iron Deficiencies Wounds and Injuries Anemia Hematologic Diseases Renal Insufficiency Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Male Urogenital Diseases Iron Metabolism Disorders Metabolic Diseases Anemia, Hypochromic Dextrans Iron-Dextran Complex Anticoagulants Plasma Substitutes Blood Substitutes Hematinics |