---
title: Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)
nct_id: NCT02232906
overall_status: COMPLETED
phase: PHASE4
sponsor: Hospital Aleman
study_type: INTERVENTIONAL
primary_condition: Iron Deficiency
countries: Argentina
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02232906.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02232906"
ct_last_update_post_date: 2014-09-05
last_seen_at: "2026-05-12T07:28:12.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)

**Official Title:** Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina

**NCT ID:** [NCT02232906](https://clinicaltrials.gov/study/NCT02232906)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Hospital Aleman
- **Collaborators:** Vifor Pharma
- **Conditions:** Iron Deficiency, Anaemia
- **Start Date:** 2011-03
- **Completion Date:** 2013-09
- **CT.gov Last Update:** 2014-09-05

## Brief Summary

Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* \>18 years of age
* Creatinine clearance ≤40 mL/min
* Hemoglobin 110-120 g/L
* Serum ferritin \<100 µg/L or transferrin saturation \<20%
* Monthly treatment with ESA and oral iron for at least six months before enrolment

Exclusion Criteria:

* Other obvious cause of acute or chronic anemia than iron deficiency
* Expectation to require hemodialysis within the next six months
* Short life expectancy (\<1 year)
* Pregnancy
* Decompensated heart failure
* History of allergic reactions to iron preparations and/or anaphylaxis from any cause
* Requirement of blood transfusions
* Chronic decompensated mental disorder or dementia
```

## Arms

- **intravenous ferric carboxymaltose** (EXPERIMENTAL)

## Interventions

- **intravenous ferric carboxymaltose** (DRUG) — Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation \>20%)

## Primary Outcomes

- **ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment** _(time frame: 6 months)_

## Secondary Outcomes

- **Anaemia and iron status** _(time frame: 6 months)_
- **Number of hospitalizations** _(time frame: 6 months)_
- **Number of transfusions** _(time frame: 6 months)_
- **Number of adverse reactions** _(time frame: 6 months)_
- **Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function** _(time frame: 6 months)_
- **Proteinuria at baseline and then bi-monthly until end of study as marker of renal function** _(time frame: 6 months)_

## Locations (1)

- Hospital Alemán, Buenos Aires, Argentina

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital alemán|buenos aires||argentina` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02232906.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02232906*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*