A Phase 3 interventional study of Molidustat (BAY85-3934) and Darbepoetin alfa in Anemia and Renal Insufficiency, Chronic, sponsored by Bayer. Completed at 59 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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Among 13 studies testing molidustat in Anemia — none open to participants now, none under way, none of them phase 3. molidustat · Anemia.
Among the 13 studies testing molidustat in Anemia, this one is the 4th largest by enrollment, is one of 2 that started in 2017, is one of 5 in phase 3, and was the 9th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →None of the 13 studies testing molidustat in Anemia is open now. The open studies under Anemia, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2017.
This study's enrollment of 164 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Median enrollment 121 across the 13 interventional studies. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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13 of 13 have an industry lead sponsor. The 1 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
14 studies in Anemia by Bayer: none open now, 1 under way, none of them phase 3. Of 13 finished, 0 (0%) have results posted.
Among the 14 studies in Anemia by Bayer, this one is the 4th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2017, is one of 5 in phase 3, and was the 9th registered.
Bayer’s Anemia studies by the year they started, since 2011.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing molidustat in Anemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bayer’s 14 in Anemia:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Molidustat group
Drug: Molidustat (BAY85-3934)
Darbepoetin alfa group
Drug: Darbepoetin alfa
Starting dose of 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response
Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response
Mean Hb (Hemoglobin) level
Time frame: From week 30 to 36
Change in hemoglobin level from baseline to the average during the evaluation period
Time frame: Baseline and week 30 to 36
Responder rate: proportion of responders among the subjects
Responder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
Time frame: From week 30 to 36
Proportion of subjects who meet each component of the response
Response: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
Time frame: From week 30 to 36
Hb level
Time frame: Baseline and up to 52 weeks
Change in Hb level
Time frame: Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Time frame: From week 30 to 36
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Time frame: From week 30 to 36
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Time frame: From week 30 to 36
Proportion of subjects whose hemoglobin levels are in the target range
Time frame: Up to 52 weeks
Proportion of subjects whose hemoglobin levels are above the target range
Time frame: Up to 52 weeks
Proportion of subjects whose hemoglobin levels are below the target range
Time frame: Up to 52 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Defined as change in Hb level / duration between two visits (weeks)
Time frame: Up to 52 weeks
Number of participants with serious adverse events
Time frame: Up to 52 weeks
Maximum concentration (Cmax) of Molidustat
Time frame: At baseline, week 12, week 24 and week 52
Area under the concentration-time curve (AUC) of Molidustat
Time frame: At baseline, week 12, week 24 and week 52
EPO (Erythropoietin) serum concentration of Molidustat
Time frame: At baseline, week 12, week 24 and week 52
Ran from Dec 2017 to primary completion in Jul 2019, 18 months.
Of 98 industry-sponsored phase 3 interventional studies under Anemia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's 18 months is below that.
Counting every sponsor, half of 150 studies reached it within 30 months; a quarter within 17 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Molidustat