DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

March 21, 2019 updated by: Daiichi Sankyo, Inc.

A Phase 1b Study, to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Repeated Doses of DS-2330b Alone and When Co-administered With Sevelamer in Patients on Chronic Hemodialysis

This three-part study will be performed with participants on chronic hemodialysis.

  • Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b
  • Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day
  • Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate

After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • DaVita Clinical Research
    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DaVita Clinical Research
      • Saint Paul, Minnesota, United States, 55114
        • Prism Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has a body mass index (BMI) of 18 kg/m^2 to 40 kg/m^2 (inclusive)
  • Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product
  • Has permanent vascular access [arteriovenous (A-V) fistula or graft]
  • Is willing to comply with protocol-specified methods for family planning

  • For Parts B and C only:

    1. Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders
    2. Has protocol-specified acceptable serum Ca^2+ level and intact parathyroid hormone (iPTH) level at screening

Exclusion Criteria:

  • Is employed by the clinic or the sponsor
  • Has family relationship with another study participant

  • Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise:

    1. safety of the participant or their children
    2. safety of study staff
    3. analysis of study results

  • For Parts B and C only:

    1. Is not able to take sevelamer carbonate
    2. Has had partial or total parathyroidectomy within the last six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: DS-2330b PIB, then Tablet
On a non-dialysis day, participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast.
Drug: DS-2330b PIB
DS-2330b as powder in bottle with stock solution (PIB)
Drug: DS-2330b Tablet
DS-2330b as tablet formulation
Experimental: Part A: DS-2330b Tablet, then PIB
On a non-dialysis day, participants are given a single 250 mg dose of DS-2330b in tablet form [Treatment A2] right after breakfast. At least 3 days will be allowed to let the first dose wash out. Then on a non-dialysis day the participants are given a single 250 mg dose of DS-2330b PIB [Treatment A1] right after breakfast.
Drug: DS-2330b PIB
DS-2330b as powder in bottle with stock solution (PIB)
Drug: DS-2330b Tablet
DS-2330b as tablet formulation
Placebo Comparator: Part B: Placebo
Participants are given placebo three times daily [Treatment B1]
Drug: Placebo
Placebo matching stock solution in bottle
Experimental: Part B: DS-2330b PIB
Participants are given 400 mg of DS-2330b PIB three times daily [Treatment B2]
Drug: DS-2330b PIB
DS-2330b as powder in bottle with stock solution (PIB)
Experimental: Part B: DS-2330b PIB + Sevelamer
Participants are given 400 mg of DS-2330b PIB along with 1.6 grams of sevelamer three times daily [Treatment B3]
Drug: DS-2330b PIB
DS-2330b as powder in bottle with stock solution (PIB)
Drug: Sevelamer
Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
Other Names:
  • Sevelamer carbonate
Experimental: Part B: Placebo + Sevelamer
Participants are given placebo along with 1.6 grams of sevelamer three times daily [Treatment B4]
Drug: Placebo
Placebo matching stock solution in bottle
Drug: Sevelamer
Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
Other Names:
  • Sevelamer carbonate
Experimental: Part C: DS-2330b Tablet + Sevelamer
Participants are given one 250 mg dose of DS-2330b in tablet form along with 1.6 grams of sevelamer three times daily [Treatment C]
Drug: DS-2330b Tablet
DS-2330b as tablet formulation
Drug: Sevelamer
Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
Other Names:
  • Sevelamer carbonate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A, Period 1: Maximum concentration (Cmax) of DS-2330a
Time Frame: Period 1, Pre-dose to 48 hours post-dose
Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: Cmax of DS-2330a
Time Frame: Period 2, Pre-dose to 48 hours post-dose
Period 2, Pre-dose to 48 hours post-dose
Part A, Period 1: Time to maximum concentration (Tmax) of DS-2330a
Time Frame: Period 1, Pre-dose to 48 hours post-dose
Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: Tmax of DS-2330a
Time Frame: Period 2, Pre-dose to 48 hours post-dose
Period 2, Pre-dose to 48 hours post-dose
Part A, Period 1: Area under the drug concentration curve (AUC) for DS-2330a over 24 hours (AUC-24)
Time Frame: Period 1, Pre-dose to 24 hours post-dose
Period 1, Pre-dose to 24 hours post-dose
Part A, Period 2: AUC for DS-2330a for DS-2330a over 24 hours (AUC-24)
Time Frame: Period 2, Pre-dose to 24 hours post-dose
Period 2, Pre-dose to 24 hours post-dose
Part A, Period 1: AUC at the last observable concentration (AUClast) and to infinity (AUCinf) for DS-2330a
Time Frame: Period 1, Pre-dose to 48 hours post-dose
Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf
Period 1, Pre-dose to 48 hours post-dose
Part A, Period 2: AUClast and AUCinf for DS-2330a
Time Frame: Period 2, Pre-dose to 48 hours post-dose
Categories (with the same unit of measure ng*hr/mL): AUClast, AUCinf
Period 2, Pre-dose to 48 hours post-dose
Parts B and C: Serum phosphate (Pi) levels before hemodialysis
Time Frame: within 15 days
within 15 days
All Parts: Number of trial participants with treatment-emergent adverse events (TEAEs)
Time Frame: through trial completion (about 15 months)
TEAEs are adverse events (side effects) associated with taking an investigational product, whether or not they were caused by the investigational product. Clinically significant changes in physical exam findings, vital signs, electrocardiograms, clinical lab tests and thyroid function are recorded as TEAEs.
through trial completion (about 15 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parts B and C: Cmax of DS-2330a
Time Frame: within 24 hours on Day 1
within 24 hours on Day 1
Parts B and C: Cmax of DS-2330a
Time Frame: within 24 hours on Day 13
within 24 hours on Day 13
Parts B and C: Tmax of DS-2330a
Time Frame: within 24 hours, Day 1
within 24 hours, Day 1
Parts B and C: Tmax of DS-2330a
Time Frame: within 24 hours, Day 13
within 24 hours, Day 13
Parts B and C: AUC-24 for DS-2330a
Time Frame: Day 1
Day 1
Parts B and C: AUC-24 for DS-2330a
Time Frame: Day 13
Day 13
Parts B and C: AUCinf for DS-2330a
Time Frame: Day 1
Day 1
Parts B and C: AUCinf for DS-2330a
Time Frame: Day 13
Day 13
Parts B and C: Minimum concentration (Ctrough) of DS-2330a
Time Frame: within 11 days
Trough blood levels for DS-2330a will be collected before the morning dose (prior to breakfast)
within 11 days
Part B: Dialysis clearance of DS-2330a
Time Frame: on Day 11
on Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS2330-A-U103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

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