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NCT01083849 · REGISTRY CONDITION SEARCH

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2014-12-19

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

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outcome · POSTED

Number of Participants With Hypercalcemia

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outcome · POSTED

Number of Participants With Hyperphosphatemia

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outcome · POSTED

Number of Participants With Elevated Calcium-Phosphorus Product

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outcome · POSTED

Mean Duration of Hospitalization by Visit

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outcome · POSTED

Mean Duration of Disability by Visit

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outcome · POSTED

Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

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outcome · POSTED

Mean Intact Parathormone (iPTH) Levels by Visit

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outcome · POSTED

Mean Calcium-Phosphate Product Levels by Visit

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease * Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study Exclusion Criteria: * The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply * An additional exclusion criterion is a parathyroid hormone- value of \> 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol
healthy Volunteers
false
minimum Age
18 Years
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
study Population
Participating sites were facilities specialized in the treatment of chronic kidney disease and offices of community-based specialists/nephrologists in Germany and Austria.
Treatment arms and interventions
arm Groups
  1. description
    Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    label
    Paricalcitol
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
761
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
    measure
    Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
    time Frame
    Up to 12 Months
  2. description
    Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
    measure
    Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
    time Frame
    Up to 12 months
secondary Outcomes
  1. description
    Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.
    measure
    Number of Participants With Hypercalcemia
    time Frame
    Months 0, 3, 6, 9, and 12
  2. description
    Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.
    measure
    Number of Participants With Hyperphosphatemia
    time Frame
    Months 0, 3, 6, 9, and 12
  3. description
    Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg\^2/dL\^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.
    measure
    Number of Participants With Elevated Calcium-Phosphorus Product
    time Frame
    Months 0, 3, 6, 9, and 12
  4. measure
    Mean Duration of Hospitalization by Visit
    time Frame
    Months 0, 3, 6, 9, and 11
  5. measure
    Mean Duration of Disability by Visit
    time Frame
    Months 0, 3, 6, 9, and 11
  6. measure
    Mean Intact Parathormone (iPTH) Levels by Visit
    time Frame
    Months 0, 3, 6, 9, and 12
  7. measure
    Mean Calcium-Phosphate Product Levels by Visit
    time Frame
    Months 0, 3, 6, 9, and 12
Full study description
brief Summary
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
detailed Description
According to protocol amendment of 16 October 2010 Austria is participating in this study. Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis. Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare. Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
Source references
see Also Links
  1. label
    Related Info
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice