NCT02021370: DIALOGUE 1

15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)

Completed Phase 2 Last updated 20 September 2019

What this trial tests

Phase 2 trial testing BAY85-3934 in Anemia in 121 participants. Completed in 23 September 2015.

Timeline

10 February 2014

Primary endpoint
15 September 2015

23 September 2015

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	121
Start date	10 February 2014
Primary completion	15 September 2015
Estimated completion	23 September 2015
Sites	56 locations across France, Italy, Japan, United Kingdom, Germany, Hungary, Israel, Poland

Drugs / interventions tested

• BAY85-3934 — full drug profile →
• Placebo

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

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.

Publications & conference data

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

1. Anaemia in kidney disease: harnessing hypoxia responses for therapy.
   Koury MJ, Haase VH. · · 2015 · cited 245× · PMID 26055355 · DOI 10.1038/nrneph.2015.82
2. 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
3. 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
4. Iron metabolism and management: focus on chronic kidney disease.
   Agarwal AK. · · 2021 · cited 31× · PMID 33777495 · DOI 10.1016/j.kisu.2020.12.003
5. 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