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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083849
First received: February 25, 2010
Last updated: December 11, 2014
Last verified: December 2014
  Purpose

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.


Condition
Kidney Insufficiency
Secondary Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months [ Time Frame: Up to 12 Months ] [ Designated as safety issue: Yes ]
    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).

  • Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants With Hypercalcemia [ Time Frame: Months 0, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Hyperphosphatemia [ Time Frame: Months 0, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Elevated Calcium-Phosphorus Product [ Time Frame: Months 0, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Duration of Hospitalization by Visit [ Time Frame: Months 0, 3, 6, 9, and 11 ] [ Designated as safety issue: No ]
  • Mean Duration of Disability by Visit [ Time Frame: Months 0, 3, 6, 9, and 11 ] [ Designated as safety issue: No ]
  • Mean Intact Parathormone (iPTH) Levels by Visit [ Time Frame: Months 0, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Mean Calcium-Phosphate Product Levels by Visit [ Time Frame: Months 0, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]

Enrollment: 761
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Paricalcitol
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083849

  Show 87 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sabine Decker-Burgard, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01083849     History of Changes
Other Study ID Numbers: P10-681
Study First Received: February 25, 2010
Results First Received: December 11, 2014
Last Updated: December 11, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AbbVie:
Observational study
Paricalcitol
Treatment of Hyperparathyroidism
Chronic kidney disease stage 3, 4 and 5 (CKD stage 3, 4 and 5)
Chronic Kidney Disease
Zemplar
sHPT
Secondary

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Endocrine System Diseases
Parathyroid Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 30, 2015