NCT01309659 is a Phase 2 clinical trial of iron sucrose in Anemia, sponsored by Duke University.

Who is sponsoring NCT01309659?

NCT01309659 is sponsored by Duke University.

What drugs are being tested in NCT01309659?

Interventions in NCT01309659: iron sucrose, iron sucrose.

What condition does NCT01309659 study?

NCT01309659 studies Anemia, Unexplained Anemia (UAE).

Is NCT01309659 still recruiting?

NCT01309659 is currently terminated. Last updated 7 January 2016.

Are results published for NCT01309659?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-01-07 · How we verify

NCT01309659

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Open-Label, Wait-list Control Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 200 ng/mL

Terminated Phase 2 Results posted Last updated 7 January 2016

What this trial tests

Phase 2 trial testing iron sucrose in Anemia in 19 participants. Terminated before completion.

Timeline

1 May 2011

Primary endpoint
1 February 2013

1 September 2014

Quick facts

Lead sponsor	Duke University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 May 2011
Primary completion	1 February 2013
Estimated completion	1 September 2014
Sites	5 locations across United States

Drugs / interventions tested

iron sucrose — full drug profile →
iron sucrose — full drug profile →

Conditions studied

Anemia — all drugs for Anemia →
Unexplained Anemia (UAE) — all drugs for Unexplained Anemia (UAE) →

Sponsor

Duke University

Who can join

65 and older, any sex, with Anemia or Unexplained Anemia (UAE). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in 6 Minute Walk Test Results
Time frame: Baseline, 12 weeks
Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.

Sponsor's own description

The purpose of this study is to determine whether treatment of unexplained anemia in older adults with a short course of weekly intravenous iron infusions can improve physical activity and therefore quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Iron therapy in anaemic adults without chronic kidney disease.
Gurusamy KS, Nagendran M, Broadhurst JF, Anker SD, et al · · 2014 · cited 38× · PMID 25550190 · DOI 10.1002/14651858.cd010640.pub2

Verify or expand the search:

Other recruiting trials for Anemia

Currently open trials in the same condition.

NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01309659 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 7 January 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01309659.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing