Renal Insufficiency, ChronicPhase 1NCT02312973
To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects
A Phase 1 study testing Molidustat(BAY85-3934) in people with Renal Insufficiency, Chronic, run by Bayer at 2 sites in Germany.
Trial summary
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Molidustat(BAY85-3934)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 14 Jan 2015to 1 Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female (without childbearing potential)
- Age: ≥18 and ≤79 years of age
- Body mass index (BMI): ≥18 and ≤34 kg/m2
- Ethnicity: White
- Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and
- Healthy subjects
Who cannot join
- Women of childbearing potential, pregnant or lactating women
- Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1/2 Ab)
- Exclusion periods from other studies or simultaneous participation in other clinical studies
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Velbert, North Rhine-Westphalia, 42549
About this study
Official title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Oral Doses of 75 mg Molidustat in Male and Female Subjects With Renal Impairment Requiring Hemo- or Peritoneal Dialysis Compared to Age- and Weight-matched Healthy Subjects in a Single-center, Non-controlled, Non-blinded Study With Group Stratification
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Molidustat(BAY85-3934)
- Keywords
- Chronic kidney disease, Pharmacokinetics, Hemodialysis, Peritoneal dialysis, Erythropoietin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molidustat(BAY85-3934)Drug
Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
Molidustat(BAY85-3934)Drug
One single oral dose of 75 mg molidustat in healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively) Receives: Drug: Molidustat(BAY85-3934) |
| Arm 2 | Experimental | Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively) Receives: Drug: Molidustat(BAY85-3934) |
| Arm 3 | Experimental | Single oral dose of 75 mg molidustat (fasted) in healthy subjects Receives: Drug: Molidustat(BAY85-3934) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics characterized by Cmax of Molidustat
Cmax: maximum drug concentration in plasma after single dose administration
Measured: Up to 96 hours post dose
Pharmacokinetics characterized by AUC of Molidustat
AUC: area under the plasma concentration vs time curve from zero to infinity
Measured: Up to 96 hours post dose
Pharmacokinetics characterized by Cmax,norm of Molidustat
Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
Measured: Up to 96 hours post dose
Pharmacokinetics characterized by (AUCnorm) of Molidustat
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
Measured: Up to 96 hours post dose
Secondary outcomes (4)
Pharmacokinetics characterized by Cmax of erythropoietin
Cmax: maximum drug concentration in plasma after single dose administration
Measured: Up to 48 hours post dose
Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
Measured: Up to 48 hours post dose
Pharmacokinetics characterized by tmax of erythropoietin
tmax: time to reach maximum drug concentration in plasma after single (first) dose
Measured: Up to 48 hours post dose
Number of subjects with Treatment Emergent Adverse Event (TEAE)
Measured: Up to 7 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study start14 Jan 2015
- Primary completion2 Dec 2015
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312973
- Sponsor's protocol ID
- 17767
- Other IDs
- 2014-003292-31, 2014
- Status last verified
- Jan 2021
- First submitted
- 5 Dec 2014
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Oral Doses of 75 mg Molidustat in Male and Female Subjects With Renal Impairment Requiring Hemo- or Peritoneal Dialysis Compared to Age- and Weight-matched Healthy Subjects in a Single-center, Non-controlled, Non-blinded Study With Group Stratification
- ClinicalTrials.gov ID
- NCT02312973
- Acronym / sponsor ID
- 17767
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease, Pharmacokinetics, Hemodialysis, Peritoneal dialysis, Erythropoietin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 2 Dec 2015 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Molidustat(BAY85-3934)Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively) |
| Arm 2 | Experimental | Drug: Molidustat(BAY85-3934)Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively) |
| Arm 3 | Experimental | Drug: Molidustat(BAY85-3934)Single oral dose of 75 mg molidustat (fasted) in healthy subjects |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female (without childbearing potential)
- Age: ≥18 and ≤79 years of age
- Body mass index (BMI): ≥18 and ≤34 kg/m2
- Ethnicity: White
- Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and
Key exclusion criteria (4 listed)
- Women of childbearing potential, pregnant or lactating women
- Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1/2 Ab)
- Exclusion periods from other studies or simultaneous participation in other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molidustat(BAY85-3934)Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis | Drug | Arm 1, Arm 2 |
| Molidustat(BAY85-3934)One single oral dose of 75 mg molidustat in healthy subjects | Drug | Arm 3 |
Primary outcome
Pharmacokinetics characterized by Cmax of Molidustat
Time frame: Up to 96 hours post dose
Cmax: maximum drug concentration in plasma after single dose administration
Pharmacokinetics characterized by AUC of Molidustat
Time frame: Up to 96 hours post dose
AUC: area under the plasma concentration vs time curve from zero to infinity
Pharmacokinetics characterized by Cmax,norm of Molidustat
Time frame: Up to 96 hours post dose
Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
Pharmacokinetics characterized by (AUCnorm) of Molidustat
Time frame: Up to 96 hours post dose
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
4 secondary outcomes
Pharmacokinetics characterized by Cmax of erythropoietin
Time frame: Up to 48 hours post dose
Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
Time frame: Up to 48 hours post dose
Pharmacokinetics characterized by tmax of erythropoietin
Time frame: Up to 48 hours post dose
Number of subjects with Treatment Emergent Adverse Event (TEAE)
Time frame: Up to 7 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Molidustat(BAY85-3934) in people with Renal Insufficiency, Chronic, run by Bayer at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics characterized by Cmax of Molidustat (time frame: Up to 96 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.