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Trial record 2 of 6 for:    BPS804

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01806610
Recruitment Status : Withdrawn
First Posted : March 7, 2013
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Chronic-kidney Disease Stage 5D on Stable Hemodialysis Drug: BPS804 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Trial of BPS804 on Safety and Tolerability in Patients With Late-stage Chronic Kidney Disease
Study Start Date : August 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: BPS804
Single dose BPS804 administration.
Drug: BPS804
Single dose BPS804 administration.
Other Name: Active BPS804.

Placebo Comparator: Placebo
Single dose placebo administration.
Drug: Placebo
Single dose placebo administration.
Other Name: BPS804 placebo.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. 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].
    2. 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.
    3. 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].
    4. Use of a combination of any two of the following (1+2 or 1+3 or 2+3):

      1. Use of oral, injected or implanted hormonal methods of contraception.
      2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
      3. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806610


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01806610     History of Changes
Other Study ID Numbers: CBPS804A2204
2012-003348-63 ( EudraCT Number )
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Randomized
Placebo-controlled trial
BPS804
Safety, tolerability, and PK
Patients with late-stage chronic kidney disease.

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs