Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease

NCT01806610 | Withdrawn Phase 2

• 2 other identifiers: CBPS804A22042012-003348-63
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic-kidney Disease Stage 5D on Stable Hemodialysis

Keywords

Randomized; Placebo-controlled trial; BPS804; Safety, tolerability, and PK; Patients with late-stage chronic kidney disease.

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing

Study Arms (2)

BPS804

EXPERIMENTAL

Single dose BPS804 administration.

Drug: BPS804

Placebo

PLACEBO COMPARATOR

Single dose placebo administration.

Drug: Placebo

Interventions

BPS804 DRUG

Single dose BPS804 administration.

Also known as: Active BPS804.

BPS804

Placebo DRUG

Single dose placebo administration.

Also known as: BPS804 placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ultragenyx Pharmaceutical Inc: lead
• Mereo BioPharma: collaborator
• Novartis: collaborator

MeSH Terms

Interventions

setrusumab

Study Officials

• Medical Director

  Ultragenyx Pharmaceutical Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2013
• First Posted: March 7, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 14, 2022

Record last verified: 2022-09