Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02232906
Other study ID # FCM-ND-CKD 2012
Secondary ID
Status Completed
Phase Phase 4
First received August 31, 2014
Last updated September 3, 2014
Start date March 2011
Est. completion date September 2013

Study information

Verified date September 2014
Source Hospital Aleman
Contact n/a
Is FDA regulated No
Health authority Argentina: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
intravenous ferric carboxymaltose
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%)

Locations

Country Name City State
Argentina Hospital Alemán Buenos Aires

Sponsors (2)

Lead Sponsor Collaborator
Hospital Aleman Vifor Pharma

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment 6 months No
Secondary Anaemia and iron status Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study 6 months No
Secondary Number of hospitalizations 6 months No
Secondary Number of transfusions 6 months No
Secondary Number of adverse reactions 6 months Yes
Secondary Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function 6 months Yes
Secondary Proteinuria at baseline and then bi-monthly until end of study as marker of renal function 6 months Yes
See also
  Status Clinical Trial Phase
Completed NCT01483768 - Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients N/A
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Recruiting NCT02242188 - Supplementing Iron and Development in Breastfed Infants (SIDBI Study) Phase 4
Completed NCT02714361 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT01991626 - Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods N/A
Completed NCT01687062 - Iron Absorption From Tef-injera in Women of Reproductive Age N/A
Completed NCT01573013 - Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children N/A
Completed NCT01443832 - Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study Phase 0
Completed NCT01191463 - The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years) N/A
Completed NCT01061307 - An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand Phase 0
Not yet recruiting NCT00515918 - The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants N/A
Recruiting NCT00378469 - Study of the Effects of Muscular Activity on Iron Metabolism N/A
Recruiting NCT05992116 - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Completed NCT05262634 - Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
Completed NCT06080555 - Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia Phase 1
Completed NCT04602247 - Evaluation of Iron Bioavailability From Iron Chlorophyllin N/A
Completed NCT02996786 - Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners N/A
Completed NCT02175888 - The Optimization of Bioavailability From Iron Supplements: Study 1 N/A