Trial · NCT01679587
Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
NCT01679587, Phase 1, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD). Trials, record NCT01679587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01679587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
- NCT number
- NCT01679587
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 49 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Kidney Diseases
- Interventions
- Molidustat (BAY85-3934), Placebo
- First posted
- 2012-09-06
- Last updated
- 2016-05-02
- Other registries' IDs
- eudract:2012-002375-33
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with adverse events | Approximately 9 weeks | |
| Primary | Blood pressure | Approximately 9 weeks | Systolic, diastolic, mean blood pressure |
| Primary | Heart rate | Approximately 9 weeks | |
| Primary | Cmax | Pre-dose and up to 48 h post-dose | Maximum observed drug concentration in measured matrix after single dose administration |
| Primary | Cmax/D | Pre-dose and up to 48 h post-dose | Cmax divided by dose |
| Primary | AUC | Pre-dose and up to 48 h post-dose | Area under the concentration vs time curve from zero to infinity after single dose |
| Primary | AUC/D | Pre-dose and up to 48 h post-dose | AUC divided by dose |
| Primary | Heart rate over 1 min | Pre-dose and up to 24 h post-dose | |
| Primary | Standing blood pressure procedure | Starting from 2 h post-dose and up to 4 h post-dose | |
| Primary | Impedance cardiography | Pre-dose and up tp 8 h post-dose | Stroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistance |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01679587
GET https://conductscience.org/api/trials/v1/NCT01679587/registered?page=2