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Zemplar Medical Research Studies

Up-to-date List of Zemplar Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Zemplar Medical Research Studies

Rank Status Study
1 Unknown  Vitamin D and Coronary Calcification Study
Conditions: Chronic Kidney Disease;   Vitamin D Deficiency;   Coronary Calcification;   Disorders of Calcium and Bone Metabolism
Interventions: Drug: Calcitriol (Rocaltrol®);   Drug: Paricalcitol
Outcome Measures: To determine prospectively if there is a differential effect on coronary artery (CAC) score progression between calcitriol and paricalcitol in patients with chronic kidney disease.;   To determine prospectively if there is a differential effect on aortic and valvular score progression and arterial stiffness in patients with chronic kidney disease receiving calcitriol and paricalcitol.;   To determine prospectively if there is a differential effect on biomarkers of vascular calcification and mineral metabolism in patients with chronic kidney disease receiving calcitriol and paricalcitol.
2 Unknown  Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
Condition: Chronic Kidney Disease
Interventions: Drug: Paricalcitol;   Drug: Paricalcitol, atorvastatin;   Drug: Atorvastatin
Outcome Measures: Concentration of oxidative enzymes and VCAM-1, ICAM-1 and TNF-α values in blood;   Progress of Nutritional and anaemia parameters;   Evaluation of Erythropoetin requirement variations
3 Recruiting Efficacy and Safety of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients
Conditions: Disorder of Transplanted Kidney;   Proteinuria;   Albuminuria
Interventions: Drug: Paricalcitol;   Drug: Placebo
Outcome Measures: The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment.;   The percentage change in urinary albumin to creatinine ratio (UACR) from baseline to the last measurement during treatment.;   The percentage change in 24-hour urinary protein excretion form baseline to the last measurement during treatment.;   The proportion of patients achieving at least a 15% reduction in the last on-treatment UPCR level from the baseline.;   Change in estimated glomerular filtration rate, blood pressure and biomarkers, including (but not limited to) C-reactive protein, plasma renin activity, aldosterone.
4 Recruiting Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Condition: Secondary Hyperparathyroidism Due to Renal Causes
Interventions: Drug: Paricalcitol;   Drug: Calcifediol
Outcome Measures: Percentage of patients with iPTH serum concentration >110 pg/mL.;   Change on iPTH serum concentration;   Percentage of patients with at least iPTH≥30% of reduction from basal level.;   Percentage of patients that reach at least a 30% iPTH reduction at the end of the study.;   Percentage of patients with iPTH levels between 70-110 pg/mL at the end of the study.;   Percentage of patient with presence of calcifications on protocol renal biopsies at 6 months after treatment en each treatment group.;   Incidence, compared and separate, of each of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.;   Presence of alloreactive T memory cells against donor's antigen at 6 months after treatment en each treatment group.;   Change on concentration of bone markers (alkaline phosphatase and osteocalcin) and FGF-23 (Fibroblast growth factor 23) at 6 months after transplantation and treatment on each treatment group.;   Percentage of patients with acute rejection at 6 months after transplantation and treatment on each treatment group.;   Percentage of patients with delayed graft function at 6 months after treatment en each treatment group.;   Percentage of patients with microalbuminuria on months 1, 3 and 6 post transplantation.;   Percentage of patients on each stage of renal function on months 1, 3 and 6 post transplantation.;   Evolution of blood pressure, speed of pulse wave, calcium-phosphorus metabolic parameters throughout the study and evolution of bone mineral density at 6 post transplantation.;   Percentage of patients with hypercalcemia on each treatment group at 6 months post transplantation.;   Evolution of anti-HLA antibodies (PRA) from basal to month 6 post-transplantation.;   Frequency of adverse events or serious adverse events that occurs during the study on each treatment group.
5 Recruiting Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
Conditions: Kidney Failure;   Secondary Hyperparathyroidism;   Hyperphosphatemia;   Hypercalcemia
Interventions: Drug: Calcitriol;   Drug: Paricalcitol
Outcome Measures: Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over.;   Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over.;   Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over.;   Amount of active vitamin D analog used during the first 3months and 6 months of the study.
6 Recruiting Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes
Condition: Type 2 Diabetes
Interventions: Drug: Paricalcitol;   Other: placebo
Outcome Measures: Changes in urinary albumin excretion from baseline at 4 month.;   Ambulatory and 24-hour blood pressure profile.
7 Recruiting A 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
Conditions: End-Stage Renal Disease;   Secondary Hyperparathyroidism
Intervention: Drug: paricalcitol
Outcome Measures: Hypercalcemia;   Intact parathyroid hormone;   Changes from baseline in chemistry and hematology lab variables;   Proportion of subjects experiencing adverse events;   Changes from baseline in electrocardiogram (ECG);   Changes from baseline in vital signs
8 Not yet recruiting Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
Condition: Proteinuria
Interventions: Drug: Paricalcitol;   Drug: Placebo
Outcome Measure: Albumin exretion
9 Recruiting Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease Stage 3 and 4
Interventions: Drug: Zemplar (paricalcitol) Capsules;   Drug: Placebo capsules
Outcome Measures: The primary efficacy-endpoint is the proportion of subjects who achieve two consecutive greater than or equal to 30 percent reductions from baseline in intact parathyroid hormone levels.;   The proportion of subjects who achieve a final intact parathyroid hormone values within Kidney Disease Outcomes Quality Initiative intact parathyroid hormone target ranges will be evaluated within each Chronic Kidney Disease stage.;   The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for calcium.;   The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for phosphorus.;   The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12).;   The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12).
10 Recruiting A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Conditions: Patients Must Have Previously Untreated Apparently Resectable Adenocarcinoma;   of the Pancreas.
Intervention: Drug: Paricalcitol
Outcome Measure: Number of Adverse Events
11 Unknown  Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
Conditions: Kidney Failure, Chronic;   Disorder of Vitamin D
Interventions: Drug: Hidroferol®;   Drug: Paricalcitol: Zemplar®;   Drug: Habitual medication
Outcome Measure: Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning.
12 Unknown  A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
Condition: Proteinuric Renal Disease
Intervention: Drug: paricalcitol (initial dose 1 mcg orally per day)
Outcome Measure:
13 Recruiting Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
Interventions: Drug: Calcitriol;   Drug: Placebo
Outcome Measures: Changes in renal function with proteinuria;   changes in sTNFR and TNF-related proteins
14 Not yet recruiting A Study to Assess the Efficacy and Safety of Cinacalcet in Pediatric Subjects With SHPT and CKD on Dialysis
Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
Interventions: Drug: Cinacalcet HCl;   Dietary Supplement: Standard of Care
Outcome Measures: Achievement of a ≥ 30% reduction from baseline in mean plasma iPTHduring the efficacy assessment period (EAP), defined as Week 17 - 20;   Achievement of a mean iPTH ≤ 300 pg/mL (31.8 pmol/L) during the EAP;   Percent change in iPTH from baseline to the mean value during the EAP;   Change in corrected total serum calcium from baseline to the mean value during the EAP;   Change in serum phosphorus from baseline to the mean value during the EAP
15 Recruiting Clinical Trial on the Use of 25-OH -D Vitamin in Haemodialysis Patients
Condition: Chronic Renal Failure
Intervention: Drug: 25-OH-D vitamin
Outcome Measures: Vital status;   Onset of non fatal myocardial infarction;   Onset of non fatal stroke;   fatal myocardial infarction;   non fatal myocardial infarction;   fatal stroke;   non fatal stroke;   sudden death;   death for other causes (not traumatic);   frequency of hypercalcemia (>10.5 mg/dl);   frequency of hyperphosphoremia (>5.5 mg/dl);   frequency of normal level of 25-OH-D vitamin (>30 ng/ml);   frequency of 25-OH-D vitamin >100 ng/ml;   frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators;   frequency of parathyroid surgery

These studies may lead to new treatments and are adding insight into Zemplar etiology and treatment.

A major focus of Zemplar research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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