NCT02787824

Brief Summary

The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose \[continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)\] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 20, 2017

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

May 24, 2016

Last Update Submit

September 19, 2017

Conditions

Anemia of Chronic Kidney Disease

Keywords

iron deficiencyhemodialysis

Outcome Measures

Primary Outcomes (1)

  • Change of serum hemoglobin level (g/dl)

    Month 0, 1, 2, 3, 4

Study Arms (2)

continuous iv administration of iron sucrose

EXPERIMENTAL

Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session).

Drug: Iron Sucrose Supplement

intermittent iv administration of iron sucrose

ACTIVE COMPARATOR

Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.

Drug: Iron Sucrose Supplement

Interventions

Iron Sucrose SupplementDRUG
continuous iv administration of iron sucroseintermittent iv administration of iron sucrose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Constant rHu-EPO and iron dose for at least 2 months before starting the study
  • Hemoglobin ≥ 8,5g/dl and \<12,5 g/dl
  • Ferritin \< 1000 mg/dl
  • TSAT \< 50%
  • CRP \< 5 mg/dl

You may not qualify if:

  • Malignant tumor disease
  • Oral iron supplementation
  • Active bleeding issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, 56403, Greece

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nephrology Dept

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 1, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 20, 2017

Record last verified: 2016-05

Locations

GR(1)