Who is sponsoring NCT01222884?

NCT01222884 is sponsored by Pharmacosmos A/S.

What drugs are being tested in NCT01222884?

Interventions in NCT01222884: Monofer, Iron sucrose.

What condition does NCT01222884 study?

NCT01222884 studies Chronic Kidney Disease Stage 5 (Dialysis Dependent).

Is NCT01222884 still recruiting?

NCT01222884 is currently completed. Last updated 2 November 2015.

Are results published for NCT01222884?

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

Last reviewed 2015-11-02 · How we verify

NCT01222884

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

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

Completed Phase 3 Results posted Last updated 2 November 2015

What this trial tests

Phase 3 trial testing Monofer in Chronic Kidney Disease Stage 5 (Dialysis Dependent) in 351 participants. Completed in 1 December 2013.

Timeline

1 June 2011

Primary endpoint
1 October 2013

1 December 2013

Quick facts

Lead sponsor	Pharmacosmos A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	351
Start date	1 June 2011
Primary completion	1 October 2013
Estimated completion	1 December 2013
Sites	1 location across India

Drugs / interventions tested

Monofer — full drug profile →
Iron sucrose — full drug profile →

Conditions studied

Chronic Kidney Disease Stage 5 (Dialysis Dependent) — all drugs for Chronic Kidney Disease Stage 5 (Dialysis Dependent) →

Sponsor

Pharmacosmos A/S — full company profile →

Who can join

18 and older, any sex, with Chronic Kidney Disease Stage 5 (Dialysis Dependent). 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.

Ability to Maintain Hemoglobin Level
Time frame: Baseline to 6 weeks
The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1

Sponsor's own description

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Publications & conference data

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

A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients.
Bhandari S, Kalra PA, Kothari J, Ambühl PM, et al · · 2015 · cited 59× · PMID 25925701 · DOI 10.1093/ndt/gfv096

Verify or expand the search:

Other Pharmacosmos A/S trials

Trials by the same sponsor.

NCT06929806 — Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chroni · Phase 3 · recruiting
NCT05545202 — A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoi · Phase 4 · not yet recruiting
NCT05874401 — Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan · Phase 4 · recruiting
NCT05179226 — Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia · Phase 3 · recruiting
NCT03466983 — A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxyma · Phase 4 · completed

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 NCT01222884 (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 Pharmacosmos A/S
Last refreshed: 2 November 2015

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/NCT01222884.

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