Chronic-kidney Disease Stage 5D on Stable HemodialysisPhase 2NCT01806610
Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease
A Phase 2 study testing BPS804 in people with Chronic-kidney Disease Stage 5D on Stable Hemodialysis, run by Ultragenyx Pharmaceutical Inc.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic-kidney Disease Stage 5D on Stable Hemodialysis
- What is being tested?
- BPS804
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Apr 2014
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Males and females aged 18 to 80 years included, with CKD-5D (GFR < 15 mL/min per 1.73m2) on stable hemodialysis as evidenced by monthly Kt/Vurea ≥ 1.20 (obtained from local laboratory) or urea reduction ratio ≥ 60% (obtained from local laboratory) for past 3 consecutive months prior to screening.
- Patient must be on maintenance renal replacement therapy (i.e., exclusively on standard hemodialysis with non-porous membrane) 3 times per week, for > 3 months before screening with a stable dialysis prescription, as defined by no change in material (i.e., dialyzer, filter/ membrane) type and dialysis duration for ≥ 4 weeks before screening.
- If patient is currently being treated with calcimimetics, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the study duration.
- If patient is currently being treated with vitamin D, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the study duration.
- Screening body mass index (BMI) between >18.5 and ≤ 35 kg/m2 and weigh of at least 50 kg.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Who cannot join
- Patients who are on peritoneal dialysis.
- Patients who had a parathyroidectomy within 3 months prior to screening or patients who have a parathyroidectomy scheduled during the course of the study.
- Patients who have a kidney transplant scheduled during the study.
- Patients with clinically symptomatic spinal stenosis.
- Women who are pregnant or nursing (lactating).
- Women of child-bearing potential who are planning a pregnancy during the course and duration of the study.
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- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during the study and for 5 half-lives (i.e., around 10 weeks) after stopping treatment. Highly effective contraception is defined as either:
- Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female study patients, the vasectomised male partner should be the sole partner for that patient].
- Use of a combination of any two of the following (1+2 or 1+3 or 2+3):
- Use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), γ-GT.
- Hemoglobin of ≤ 9 g/dL in male, and ≤ 8 g/dL in female patients. (Note: Treatment with erythropoietin-stimulating agents (ESA) is allowed).
About this study
Official title: A Randomized, Placebo-controlled Trial of BPS804 on Safety and Tolerability in Patients With Late-stage Chronic Kidney Disease
The purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.
Read the detailed description
This study was previously posted by Novartis and was transferred to Ultragenyx in February 2021.
- Being tested
- BPS804, Placebo
- Keywords
- Randomized, Placebo-controlled trial, BPS804, Safety, tolerability, and PK, Patients with late-stage chronic kidney disease.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPS804Drug
Also called Active BPS804.
Single dose BPS804 administration.
PlaceboDrug
Also called BPS804 placebo.
Single dose placebo administration.
| Study group | Role | What they receive |
|---|---|---|
| BPS804 | Experimental | Single dose BPS804 administration. Receives: Drug: BPS804 |
| Placebo | Placebo comparator | Single dose placebo administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events after a single administration of BPS804
Adverse events will be counted within each treatment and study part. The numbers and percentages of adverse events will be tabulated by body system, preferred term, and severity.
Measured: 17 weeks
Secondary outcomes (6)
Pharmacokinetic (PK) of BPS804 in serum: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration
AUClast: The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration
Measured: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: area under the serum concentration-time curve from time zero to infinity
AUCinf: The area under the serum concentration-time curve from time zero to infinity
Measured: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: observed maximum serum concentration following drug administration
Cmax: The observed maximum serum concentration following drug administration
Measured: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: terminal elimination half-life
T1/2: The terminal elimination half-life
Measured: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: time to reach the maximum concentration after drug administration
Tmax: The time to reach the maximum concentration after drug administration
Measured: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
Concentration of BPS804 in dialysate 48 hours after dosing
Quantify BPS804 in dialysate 48 hours after dosing to assess any impact of dialysis on BPS804
Measured: Day 3, 48 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic-kidney Disease Stage 5D on Stable HemodialysisStudies of the same condition, open and under way.
- More trials run by Ultragenyx Pharmaceutical IncThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mereo BioPharma, Novartis
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Ultragenyx Pharmaceutical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806610
- Sponsor's protocol ID
- CBPS804A2204
- Other IDs
- 2012-003348-63
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2013
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Trial of BPS804 on Safety and Tolerability in Patients With Late-stage Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01806610
- Acronym / sponsor ID
- CBPS804A2204
- Keywords
- Randomized, Placebo-controlled trial, BPS804, Safety, tolerability, and PK, Patients with late-stage chronic kidney disease.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ultragenyx Pharmaceutical IncIndustry (pharma, biotech, devices)
- Collaborators
- Mereo BioPharma, Novartis
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 7 Mar 2013 (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 purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.
Detailed description
This study was previously posted by Novartis and was transferred to Ultragenyx in February 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPS804 | Experimental | Drug: BPS804Single dose BPS804 administration. |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose placebo administration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent must be obtained before any assessment is performed.
- Males and females aged 18 to 80 years included, with CKD-5D (GFR < 15 mL/min per 1.73m2) on stable hemodialysis as evidenced by monthly Kt/Vurea ≥ 1.20 (obtained from local laboratory) or urea reduction ratio ≥ 60% (obtained from local laboratory) for past 3 consecutive months prior to screening.
- Patient must be on maintenance renal replacement therapy (i.e., exclusively on standard hemodialysis with non-porous membrane) 3 times per week, for > 3 months before screening with a stable dialysis prescription, as defined by no change in material (i.e., dialyzer, filter/ membrane) type and dialysis duration for ≥ 4 weeks before screening.
- If patient is currently being treated with calcimimetics, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the study duration.
- If patient is currently being treated with vitamin D, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the study duration.
Key exclusion criteria (17 listed)
- Patients who are on peritoneal dialysis.
- Patients who had a parathyroidectomy within 3 months prior to screening or patients who have a parathyroidectomy scheduled during the course of the study.
- Patients who have a kidney transplant scheduled during the study.
- Patients with clinically symptomatic spinal stenosis.
- Women who are pregnant or nursing (lactating).
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 |
|---|---|---|
| BPS804Also: Active BPS804.Single dose BPS804 administration. | Drug | BPS804 |
| PlaceboAlso: BPS804 placebo.Single dose placebo administration. | Drug | Placebo |
Primary outcome
Occurrence of adverse events after a single administration of BPS804
Time frame: 17 weeks
Adverse events will be counted within each treatment and study part. The numbers and percentages of adverse events will be tabulated by body system, preferred term, and severity.
6 secondary outcomes
Pharmacokinetic (PK) of BPS804 in serum: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration
Time frame: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: area under the serum concentration-time curve from time zero to infinity
Time frame: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: observed maximum serum concentration following drug administration
Time frame: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: terminal elimination half-life
Time frame: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
PK of BPS804 in serum: time to reach the maximum concentration after drug administration
Time frame: Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing
Concentration of BPS804 in dialysate 48 hours after dosing
Time frame: Day 3, 48 hours post dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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.
Medical Director study director
Ultragenyx Pharmaceutical Inc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPS804 in people with Chronic-kidney Disease Stage 5D on Stable Hemodialysis, run by Ultragenyx Pharmaceutical Inc.
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 7 inclusion and 17 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: withdrawn, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of adverse events after a single administration of BPS804 (time frame: 17 weeks). 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 14 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.