Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the effects of acute intravenous iron administration on the endothelial function in non-dialysis Chronic Kidney Disease stages G3-G5 patients with anemia and iron deficiency, in relation to changes in oxidative and nitrosative status.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Iron in Patients With Anemia of Chronic Kidney Disease

NCT00204256

Kidney Failure, Chronic

UNKNOWN PHASE4

Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

NCT00233597

Anemia

COMPLETED PHASE3

Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

NCT00236977

Anemia

COMPLETED PHASE3

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

NCT00224042

Anemia, Iron-Deficiency Kidney Failure, Chronic

COMPLETED PHASE4

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

NCT00224055

Anemia, Iron-Deficiency Kidney Failure, Chronic

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Anemia Iron Toxicity Oxidative Stress Endothelial Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.

Group Type PLACEBO_COMPARATOR

Sodium Chloride 0.9% Intravenous Solution

Intervention Type DRUG

Physiologic saline infusion will be infused in day 1.

Ferinject

Intervention Type DRUG

Ferric carboxymaltose will be infused in day 2.

Ferric carboxymaltose

Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.

Group Type ACTIVE_COMPARATOR

Sodium Chloride 0.9% Intravenous Solution

Intervention Type DRUG

Physiologic saline infusion will be infused in day 1.

Ferinject

Intervention Type DRUG

Ferric carboxymaltose will be infused in day 2.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Chloride 0.9% Intravenous Solution

Physiologic saline infusion will be infused in day 1.

Intervention Type DRUG

Ferinject

Ferric carboxymaltose will be infused in day 2.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Physiologic saline Ferric carboxymaltose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria);
* Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum ferritin \< 100 ng/mL and/or TSAT \< 20% (KDIGO).

Exclusion Criteria

* contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin \> 500 ng/mL and/or transferrin saturation \> 50%);
* treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously);
* active smoker status;
* antioxidant food supplements treatment in the last 3 months;
* clinically manifest bleeding;
* another cause of anemia (hemoglobinopathies, vitamin B12 and/or folic acid deficiency suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma and other paraproteinemias);
* severe anemia (Hb \< 7 g/dl);
* baseline FMD \< 7% (the existence of atherosclerosis which limits arterial reactivity);
* cancer (currently or in the past 6 months);
* hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment ≥ grade Child B;
* autoimmune disorders or significant inflammation (as defined by C-reactive protein \> 5 mg/L);
* pregnancy or lactation;
* participation in other clinical trials over the upast 3 months;
* patient unwillingness.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No