- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01806610
Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease
A Randomized, Placebo-controlled Trial of BPS804 on Safety and Tolerability in Patients With Late-stage Chronic Kidney Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- 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.
Exclusion Criteria
- 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.
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BPS804
Single dose BPS804 administration.
|
Single dose BPS804 administration.
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Single dose placebo administration.
|
Single dose placebo administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
17 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
AUClast: The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration
|
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
|
AUCinf: The area under the serum concentration-time curve from time zero to infinity
|
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
|
Cmax: The observed maximum serum concentration following drug administration
|
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
|
T1/2: The terminal elimination half-life
|
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
|
Tmax: The time to reach the maximum concentration after drug administration
|
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
|
Quantify BPS804 in dialysate 48 hours after dosing to assess any impact of dialysis on BPS804
|
Day 3, 48 hours post dosing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBPS804A2204
- 2012-003348-63 (EUDRACT_NUMBER)
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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