CompletedPhase 1

Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease)

Germany44 participantsStarted 2011-04

Plain-language summary

The drug that is under investigation during this study is BAY85-3934 which is intended to be used as a treatment for patients suffering from renal anemia due to chronic kidney disease (stage 3 and 4). The purpose of this study is to provide safety and tolerability information on the drug. Other objectives of the study are to investigate the effect of the drug on the body (pharmacodynamics) as well as the absorption, breakdown, metabolism, distribution and excretion (pharmacokinetics) by measuring the concentration in blood and urine. The study will be conducted in one study center in the United Kingdom and several centers in Germany. 84 (of which 36 are optional) patients who meet the inclusion criteria will participate in the study. BAY 85-3934 will be given following a combined single / multiple dose escalation design in seven (of which three are optional) dose steps.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The informed consent must be signed before any study specific tests or procedures are done * Renal anemia due to CKD (stage 3 and 4) not on dialysis assessed by medical history and Creatine Clearance (CLCR) between 15 to 59 mL/min ± 10 % (ie CLCR between 13 - 65 mL/min) estimated at the pre-study visit from the creatinine concentration measured in serum (Modification of Diet in Renal Disease (MDRD) formula) * Stable renal disease, ie without major changes in therapy within the last 6 weeks and not expected to begin dialysis within the study. * Female subjects with no child-bearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum FSH levels \> 30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy). * Male subjects who agree to use two forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration. * Male subjects who agree not to act as sperm donors for 12 weeks after dosing. * Age: ≥ 18 and ≤ 85 years at the pre-study visit * Body mass index (BMI): ≥ 18 and ≤ 35 kg / m2 at the pre-study visit * Hemoglobin (Hb) of 8.0 - 12 g/dL (male) or 8.0 - 11.5 g/dL (female) at two consecutive measurements (1 measurement performed within 12 weeks to 2 days before the pre-study visit during routine diagnostic…

What they're measuring

Number of Subjects with Treatment-Emergent Adverse Events (TEAE)

Timeframe: From start of study drug administration until last follow-up visit (14 days after the last study drug administration)

Mean Change in Heart Rate Within 4 hours Post-dose

Timeframe: Within 4 hours from after administration of study drug on Day 1 and Day 14

Mean Change in Heart Rate Over 1 Minute for Doses 25, 50, 75 Milligrams

Timeframe: From start of study drug administration until 12 hours after the last study drug administration

Mean Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Within 4 hours Post-dose

Timeframe: Within 4 hours post-dose at Day 1 and Day 14

Number of Subjects with Clinically Relevant Abnormal Findings in the Electrocardiogram (ECG)

Timeframe: Day 1 and Day 14

Number of Subjects with Clinically Relevant Laboratory Values

Timeframe: Day 1 and Day 14

Maximum Observed Drug Concentration (Cmax) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat

Timeframe: Single dose: 0-48 hours post-dose

Trial details

NCT IDNCT01332942

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Anemia trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects with Treatment-Emergent Adverse Events (TEAE)

Timeframe: From start of study drug administration until last follow-up visit (14 days after the last study drug administration)

Mean Change in Heart Rate Within 4 hours Post-dose

Timeframe: Within 4 hours from after administration of study drug on Day 1 and Day 14

Mean Change in Heart Rate Over 1 Minute for Doses 25, 50, 75 Milligrams

Timeframe: From start of study drug administration until 12 hours after the last study drug administration

Mean Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Within 4 hours Post-dose

Timeframe: Within 4 hours post-dose at Day 1 and Day 14

Number of Subjects with Clinically Relevant Abnormal Findings in the Electrocardiogram (ECG)

Timeframe: Day 1 and Day 14

Number of Subjects with Clinically Relevant Laboratory Values

Timeframe: Day 1 and Day 14

Maximum Observed Drug Concentration (Cmax) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat

Timeframe: Single dose: 0-48 hours post-dose