Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
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Purpose
This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease patients on hemodialysis. The evaluation of outcomes of VDR activator treatments in clinical practice is a major challenge in the management of this patient population. The aim of this post-marketing observational study is to obtain further data on the outcomes of Zemplar Injection administration during routine clinical use.
| Condition | Intervention |
|---|---|
|
Parathyroid Hormone |
Drug: Zemplar iv (paricalcitol iv) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A One-year, Multicountry, Multicenter Study of Zemplar Injections in Patients With End Stage Chronic Kidney Disease, Undergoing Hemodialysis, Not Adequately Controlled With Oral Vitamin D Receptor Activator (Calcitriol or Alfacalcidol) |
- Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
- Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL) [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.
- Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]The average time (measured in days) to achieve target iPTH levels.
- Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements. [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: Yes ]Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.
| Enrollment: | 181 |
| Study Start Date: | September 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
End stage chronic kidney disease
Secondary hyperparathyroidism defined as intact PTH > 300 pg/mL
|
Drug: Zemplar iv (paricalcitol iv)
Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.
Other Name: Zemplar iv
|
Detailed Description:
This study is a non-interventional, observational study in which Zemplar® Injection is prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics (SmPC) with regards to dose, population and indication. The study population consists of participants receiving hemodialysis in whom the diagnosis of secondary hyperparathyroidism has been established, and who are not adequately controlled with the oral VDR activator (calcitriol or alfacalcidol). Participants will be included via consecutive sampling. To be included, participants should have a clinical indication to initiate treatment with Zemplar® Injection due to: (1) a diagnosis of secondary hyperparathyroidism and (2) because they require a change in treatment for secondary hyperparathyroidism (e.g. due to a lack of effectiveness of the previous treatment). Each participant will be observed during his/her Zemplar® Injection treatment regimen for a maximum period of 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Haemodialysis patients
Inclusion Criteria:
- Subject is more than 18 years of age and diagnosed with secondary hyperparathyroidism and has a pretreatment iPTH > 300 pg/mL, receiving chronic hemodialysis.
- Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
Exclusion Criteria:
- Subject has a corrected serum calcium >10.5 mg/dL, serum phosphorus > 6.5 mg/dL or subjects with corrected Ca x P>65.
- Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients, or has participated in clinical study within the last month
Contacts and Locations| Croatia | |
| Site Reference ID/Investigator# 27525 | |
| Dubrovnik, Croatia, 20000 | |
| Site Reference ID/Investigator# 27531 | |
| Imotski, Croatia, 21260 | |
| Site Reference ID/Investigator# 6175 | |
| Karlovac, Croatia, 47000 | |
| Site Reference ID/Investigator# 27528 | |
| Pula, Croatia, 52100 | |
| Site Reference ID/Investigator# 27533 | |
| Rijeka, Croatia, 51000 | |
| Site Reference ID/Investigator# 27524 | |
| Sibenik, Croatia, 22000 | |
| Site Reference ID/Investigator# 27523 | |
| Sisak, Croatia, 44000 | |
| Site Reference ID/Investigator# 27529 | |
| Slavonski Brod, Croatia, 35000 | |
| Site Reference ID/Investigator# 27530 | |
| Split, Croatia, 1000 | |
| Site Reference ID/Investigator# 27534 | |
| Trogir, Croatia, 21220 | |
| Site Reference ID/Investigator# 27522 | |
| Vinkovci, Croatia, 32000 | |
| Site Reference ID/Investigator# 27527 | |
| Zadar, Croatia, 23000 | |
| Site Reference ID/Investigator# 27526 | |
| Zagreb, Croatia, 10000 | |
| Site Reference ID/Investigator# 27532 | |
| Zagreb, Croatia, 10000 | |
| Serbia | |
| Site Reference ID/Investigator# 27536 | |
| Beograd, Serbia, 11000 | |
| Site Reference ID/Investigator# 27539 | |
| Beograd, Serbia, 11000 | |
| Site Reference ID/Investigator# 27538 | |
| Beograd, Serbia, 11000 | |
| Site Reference ID/Investigator# 27540 | |
| Beograd, Serbia, 11080 | |
| Site Reference ID/Investigator# 6169 | |
| Beograd, Serbia, 11000 | |
| Site Reference ID/Investigator# 27535 | |
| Bor, Serbia, 19210 | |
| Site Reference ID/Investigator# 27537 | |
| Kragujevac, Serbia, 34000 | |
| Study Director: | Marta Gunjaca, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01084538 History of Changes |
| Other Study ID Numbers: | P10-231 |
| Study First Received: | February 22, 2010 |
| Results First Received: | June 30, 2011 |
| Last Updated: | September 19, 2011 |
| Health Authority: | Croatia: Agency for Medicinal Product and Medical Devices Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Keywords provided by Abbott:
|
paricalcitol iv vitamin D secondary hyperparathyroidism hemodialysis |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 18, 2013