Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients With Paricalcitol in German and Austrian Clinical Practice (TOP)
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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 | Intervention |
|---|---|
|
Kidney Insufficiency Secondary Hyperparathyroidism |
Drug: Zemplar (paricalcitol) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients With Paricalcitol in German and Austrian Clinical Practice |
- Chronic Kidney Disease relevant laboratory parameters [ Time Frame: Every month for 1 year ] [ Designated as safety issue: Yes ]
- 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 ]
- Laboratory parameter of proteinuria [ Time Frame: Every month for 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Drug: Zemplar (paricalcitol)
Dosage, dosage interval and dosage form (intravenously or oral) individually chosen by the treating physician
Other Name: ABT-358
|
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 |
Patients with chronic kidney disease and a diagnosis of secondary hyperparathyroidism.
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
- Patients 18 years of age
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
Show 78 Study Locations| 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: | March 12, 2013 |
| 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 May 16, 2013