Long-Term Therapy Outcomes When Treating Chronic Kidney Disease 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: January 8, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® 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 Zemplar® injection and Zemplar® 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:
  • Chronic Kidney Disease relevant laboratory parameters [ Time Frame: Every month for 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Laboratory parameter of hypercalcemia [ Time Frame: Every month for 1 year ] [ Designated as safety issue: Yes ]
  • Laboratory parameter of hyperphosphatemia [ Time Frame: Every month for 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 683
Study Start Date: November 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Zemplar (paricalcitol) group
Patients with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with Zemplar® (paricalcitol) for at least 6 months prior inclusion in this study, over the age of 18 years, PTH- value of not more than 1000 pg/ml

Detailed Description:

According to protocol amendment of 16 Oct 2010 Austria is participating in this study.

Zemplar® injection (paricalcitol i.v.) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in patients needing dialysis. In April 2008 in Germany and in January 2008 in Austria, Zemplar® capsules (paricalcitol for oral use) 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 patients 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 Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® 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 Zemplar® injection and Zemplar® capsules in long-term use.

The primary aim of the study is to determine (i) the percentage of patients achieving an iPTH level within the target range of K/DQOI treatment guidelines (Chronic Kidney Disease 3: 35 - 70 pg/ml; Chronic Kidney Disease 4: 70 - 110 pg/ml; Chronic Kidney Disease 5: 150 - 300 pg/ml) during 12-month treatment with Zemplar®, (ii) the time it takes to achieve this level of response and whether it is sustained.

Secondary objectives are analysis of episodes of hypercalcemia, hyperphosphatemia and calcium phosphate product, dipstick proteinuria, health economics aspects (e.g. days off sick, hospitalizations), quality of life, adverse events, eGFR, compliance and other lab markers such as alkaline phosphatase, creatinine, 25-OH vitamin D and C-reactive protein (CRP) during the first 12 months of treatment with Zemplar®.

  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

Patients with chronic kidney disease and a diagnosis of secondary hyperparathyroidism.

Criteria

Inclusion Criteria:

  • The inclusion criteria are based on the Summary of Product Characteristics for Zemplar® injection and Zemplar® capsules (Appendix I and II): Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease.
  • Patients not treated with Zemplar® (paricalcitol) for at least 6 months prior to inclusion in this study

Exclusion Criteria:

  • The contraindications listed in the Summary of Product Characteristics for Zemplar® injection and Zemplar® capsules apply (Appendix I and II)
  • 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 Zemplar® (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 83 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Principal Investigator: Helmut Geiger, MD Klinikum der J.W. Goethe Iniversität
  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
Last Updated: January 8, 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, Chronic
Kidney Failure, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Ergocalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014