Paricalcitol: Zemplar

CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.

{m} Entries

Phase
Study Indication or Disease
Study Name
M10-312 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 2 Phase II Study of Paricalcitol Injection - Extension long-term safety study of paricalcitol injection in chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism
M04-692 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG Effect of Ketoconazole on the Pharmacokinetics of Paricalcitol in Healthy Subjects. Abbott Laboratories (Abbott) will use r…
P12-270 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS Post Marketing Observational Study to Assess Patient Management Practices and Quality of Life with the Capsules Form of Paricalcitol in the Treatment of SHPT in Stage 3 – 5 Chronic Kidney Disease Patients Not Yet on Dialysis Under Conditions of Usual Clinical Care (CAPITOL)
P12-838 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS Prospective, Open-label, Multicenter effectiveness and safety observational study of Zemplar in patients with stage 5 chronic kidney disease and hyperparathyroidism on hemodialysis in the Russian Federation
P10-680 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS Postmarketing Observational Study to Evaluate the Effect of Zemplar (paricalcitol IV) on Cardiac Morbidity in Patients with Chronic Kidney Disease Stage 5 over 2 Years
M02-516 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects With Stage V Chronic Kidney Disease on Hemodialysis
P12-053 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS A Prospective, Multicenter Study to Evaluate the Safety of Vitamin D Receptor Activators as Determined by Hypercalcemia in Pediatric Patients ages 0 to 16 with Chronic Kidney Disease (CKD) Stage 5 Receiving Peritoneal Dialysis (PD) within Current Clinical Practice
W12-645 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 A Prospective, Non-randomized, Single arm, Open-Label, Pilot Clinical Study Evaluating The Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients
M10-149 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 3 A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 years with Moderate to Severe Chronic Kidney Disease
M11-612 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 3 A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
2001020 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase III, Prospective, Randomized, Placebo-controlled, Double-blind, Multi-center Study to Determine the Safety and Efficacy…
M01-395 AbbVie_IU_icons_outlined_v3 Hypocalcemia CSR.ORG A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Pilot Study to Examine the Safety and Efficacy of Zemplar® to Increase…
2001019 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase III, Prospective, Randomized, Placebo-controlled, Double-blind, Multi-center Study to Determine the Safety and Efficacy…
M01-375 AbbVie_IU_icons_outlined_v3 Kidney Disease CSR.ORG A Phase 4, Double-Blind, Double-Dummy, Single-Center, Randomized, Active- Controlled, Cross-Over, Pilot Study to Evaluate the E…
W10-677 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 Effectiveness and Safety of a 6-Month Treatment With IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
M03-635 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar® Cap…
2001022 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase 4, Double-Blind, Placebo-Controlled, Multi-Center Study to Determine the Safety and Effectiveness of Zemplar® (Paricalci…
2001015 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy o…
M04-726 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis
M10-309 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 2 Late Phase II Study of Paricalcitol Injection Dose-response study of paricalcitol injection in chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism (Examination of initial dose and incremental dose)
P13-785 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS A Prospective, Multicenter, Six-Month Study on the Effectiveness, Safety and Impact on Health related Quality of Life (HRQoL) and Depression Symptoms of Paricalcitol administered to Venezuelan Patients with Chronic Kidney Disease (Stage V) who are on Hemodialysis
M01-367 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase IV Randomized, Active-Controlled, Double-Blind, Multi-Center Study to Compare Two Methods of Dosing Zemplar® Injection i…
2001021 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase III, Prospective, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Determine the Safety and Efficacy…
M03-633 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG Phase I, Single and Multiple Dose Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Zemplar Capsule in Su…
M10-030 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 3 The PRIMO Study: Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3/4
M06-823 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 3 A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis
M11-517 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 3 Comparison of Efficacy and Safety of Paricalcitol Injection with Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis with Secondary Hyperparathyroidism
W10-131 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
P12-269 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries
W10-129 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis
P10-681 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS Long-Term Therapy Outcomes when treating CKD-patients with Paricalcitol in German Clinical Practice (TOP study)
P12-776 AbbVie_IU_icons_outlined_v3 Kidney Disease PMOS Quality of Life in Greek Hemodialysis Patients Receiving Zemplar I.V. – Qualitize Study
J-ZEM-05-002 AbbVie_IU_icons_outlined_v3 Hyperparathyroidism CSR.ORG A Phase 2, Open-label, Multicenter, Multidose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Inje…
M05-741 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 2 VITAL Study - Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated with Renin-angiotensin System Inhibitors
M10-967 AbbVie_IU_icons_outlined_v3 Kidney Disease Phase 4 Study to Evaluate the Improved Management of iPTH with Paricalcitol-centered Therapy vs. Cinacalcet Therapy with Low-dose Vitamin D in Hemodialysis Patients with Secondary Hyperparathyroidism