Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006499

Trial Description

start of 1:1-Block title

Title

Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 Years With Moderate to Severe Chronic Kidney Disease

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels
in children ages 10 to 16 with Chronic Kidney Disease.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The study consists of two parts. Part I is an open-label single-dose, non-fasting,
multicenter study to evaluate the pharmacokinetics of paricalcitol capsules in 12 pediatric
subjects ages 10 to 16 years with Chronic Kidney Disease Stages 3 and 4. Part II of this
study will be conducted as a 12 week randomized double-blind, placebo-controlled study,
followed by 12 weeks open-label treatment. Subjects active or enrolled under amendment 5
will enter a Follow-Up period and have study visits every 4 weeks until the final subject
reaches Week 24. The objective of this multicenter study is to evaluate the safety and
efficacy of paricalcitol capsules in decreasing serum intact parathyroid hormone levels to
the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative target goals in
36 pediatric subjects ages 10 to 16 years with Chronic Kidney Disease Stages 3 and 4.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006499
  •   2015/01/19
  •   2009/11/13
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2010-019439-37 
  •   NCT01020487  (ClinicalTrials.gov)
  •   M10-149  (AbbVie (prior sponsor, Abbott))
  •   2010-019439-37 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Chronic Kidney Disease Stage 3 and 4
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Zemplar (paricalcitol) Capsules
  •   Drug: Placebo capsules
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- The primary efficacy-endpoint is the proportion of subjects who achieve two consecutive greater than or equal to 30 percent reductions from baseline in intact parathyroid hormone levels.; time frame: 12 Weeks; The primary efficacy measure for intact parathyroid hormone in pediatric Chronic Kidney Disease subjects is determined by the stage of Chronic Kidney Disease. The data is collected via blood draws.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- The proportion of subjects who achieve a final intact parathyroid hormone values within Kidney Disease Outcomes Quality Initiative intact parathyroid hormone target ranges will be evaluated within each Chronic Kidney Disease stage.; time frame: 12 Weeks
- The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for calcium.; time frame: 12 Weeks
- The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for phosphorus.; time frame: 12 Weeks
- The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12).; time frame: 2 Weeks
- The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12).; time frame: 4 Weeks
- The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12).; time frame: 8 Weeks
- The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12).; time frame: 12 Weeks
- The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12).; time frame: 4 Weeks
- The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12).; time frame: 8 Weeks
- The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12).; time frame: 12 Weeks

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Germany
  •   Portugal
  •   Puerto Rico
  •   Singapore
  •   Spain
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2010/02/27
  •   48
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   16   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Subject has Chronic Kidney Disease Stage 3 or 4 as determined by estimated Glomerular
Filtration Rate (15 to 59 mL/min/1.73 m2) at Screening.

- Subject is not expected to begin dialysis for at least 6 months (in the opinion of
the investigator).

- For entry into the Washout Period (for subjects who are currently on a VDRA and need
to complete a 2 to 4 week washout), the subject must satisfy the following criteria
based on the Screening laboratory values:

- estimated Glomerular Filtration Rate between 15 to 59 mL/min/1.73 m2 (estimate
by the Schwartz formula as outlined in Section 5.3.1.2).

- iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or
greater than or equal to 90 pg/mL (Stage 4 subjects).

- An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L)
to less than or equal to 10.5 mg/dL (2.63 mmol/L).

- A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but
less than or equal to 6.0 mg/dL (1.94 mmol/L).

- For entry into the Treatment Phase (Vitamin D Receptor Activator naïve subjects and
those that have completed a 4 week washout), the subject must have:

- iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or
greater than or equal to 110 pg/mL (Stage 4 subjects).

- An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L)
but less than or equal to 10.2 mg/dL (2.55 mmol/L).

- A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but
less than or equal to 5.8 mg/dL (1.87 mmol/L).

- Must have 25-hydroxyvitamin D levels ≥ 30 ng/mL prior to washout, if not VDRA
naïve, or treatment in Part II of the study.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- All subjects that have had a small bowel transplant will be excluded from the study.

- Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined
as an acute rise in serum creatinine).

- Subject has had symptomatic or significant hypocalcemia requiring active Vitamin D
therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol)
within 6 months prior to the Screening Phase.

- Subject has a history of active kidney stones (6 months prior to screening).

- Subject has chronic gastrointestinal disease, which in the investigator's opinion may
cause significant gastrointestinal malabsorption.

- Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet,
glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other
drugs known to affect calcium or bone metabolism within 4 weeks prior to Treatment.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • AbbVie (prior sponsor, Abbott)
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • AbbVie
    • Ann Eldred, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • AbbVie
    • Ann Eldred, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.