NCT01975818 (DIALOGUE4) is a Phase 2 clinical trial of Molidustat (BAY 85-3934) in Anemia, sponsored by Bayer.

Who is sponsoring NCT01975818?

NCT01975818 is sponsored by Bayer.

What drugs are being tested in NCT01975818?

Interventions in NCT01975818: Molidustat (BAY 85-3934), Epoetin alfa/beta.

What condition does NCT01975818 study?

NCT01975818 studies Anemia, Renal Insufficiency, Chronic.

Is NCT01975818 still recruiting?

NCT01975818 is currently completed. Last updated 20 September 2019.

Last reviewed 2019-09-20 · How we verify

NCT01975818: DIALOGUE4

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

Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

Completed Phase 2 Last updated 20 September 2019

What this trial tests

Phase 2 trial testing Molidustat (BAY 85-3934) in Anemia in 201 participants. Completed in 15 December 2015.

Timeline

28 October 2013

Primary endpoint
23 October 2015

15 December 2015

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	201
Start date	28 October 2013
Primary completion	23 October 2015
Estimated completion	15 December 2015
Sites	35 locations across Japan, United States

Drugs / interventions tested

Molidustat (BAY 85-3934) — full drug profile →
Epoetin alfa/beta — full drug profile →

Conditions studied

Anemia — all drugs for Anemia →
Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Anemia or Renal Insufficiency, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting iron metabolism in drug discovery and delivery.
Crielaard BJ, Lammers T, Rivella S. · · 2017 · cited 279× · PMID 28154410 · DOI 10.1038/nrd.2016.248
Anaemia in kidney disease: harnessing hypoxia responses for therapy.
Koury MJ, Haase VH. · · 2015 · cited 245× · PMID 26055355 · DOI 10.1038/nrneph.2015.82
Burden of Anemia in Chronic Kidney Disease: Beyond Erythropoietin.
Hanna RM, Streja E, Kalantar-Zadeh K. · · 2021 · cited 114× · PMID 33123967 · DOI 10.1007/s12325-020-01524-6
Effects of Molidustat in the Treatment of Anemia in CKD.
Macdougall IC, Akizawa T, Berns JS, Bernhardt T, et al · · 2019 · cited 82× · PMID 30559105 · DOI 10.2215/cjn.02510218
Iron metabolism and management: focus on chronic kidney disease.
Agarwal AK. · · 2021 · cited 31× · PMID 33777495 · DOI 10.1016/j.kisu.2020.12.003
Challenging patient phenotypes in the management of anaemia of chronic kidney disease.
Pramod S, Goldfarb DS. · · 2021 · cited 7× · PMID 34331826 · DOI 10.1111/ijcp.14681

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 Bayer trials

Trials by the same sponsor.

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NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · 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 NCT01975818 (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 Bayer
Last refreshed: 20 September 2019

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/NCT01975818.

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