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Calcijex Medical Research Studies

Up-to-date List of Calcijex 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 Calcijex 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 Recruiting Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Dietary Supplement: calcitriol;   Drug: cisplatin;   Drug: gemcitabine hydrochloride;   Other: pharmacological study
Outcome Measures: MTD of oral calcitriol when combined with a standard dose of gemcitabine hydrochloride and cisplatin, determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0;   Toxicity of this combination, graded according to NCI CTCAE version 4.0;   Pharmacokinetic (PK) analyses of calcitriol at the MTD in an expanded cohort of 6 patients, including peak levels, area under the concentration-time curve from time 0-72 hours, terminal half-life, volume of distribution, and total body clearance;   Objective tumor response, described using Response Evaluation Criteria in Solid Tumors 1.1
3 Unknown  Calcitriol in Advanced Intrahepatic Cholangiocarcinoma
Condition: Advanced Intrahepatic Cholangiocarcinoma
Intervention: Drug: Calcitriol
Outcome Measures: To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.;   To assess quality of life (QOL) of patients who are received calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.;   To assess the response of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin in patients with advanced intrahepatic cholangiocarcinoma.
4 Recruiting Calcitriol in Preventing Lung Cancer in High-Risk Patients
Condition: Squamous Lung Dysplasia
Interventions: Drug: calcitriol;   Other: pharmacological study
Outcome Measure: Number of patients with grade III-IV toxicities or grade 2 toxicities that persist more than 2 weeks , graded according to the Common Terminology Criteria for Adverse Events (CTCAE) 3.0
5 Recruiting Calcitriol, Ketoconazole, and Hydrocortisone in Treating Patients With Advanced or Recurrent Prostate Cancer
Condition: Prostate Cancer
Interventions: Dietary Supplement: calcitriol;   Drug: ketoconazole;   Drug: therapeutic hydrocortisone
Outcome Measures: Maximum tolerated dose of calcitriol (phase I);   Prostate-specific antigen response rate (complete and partial) (phase II);   Toxicity as measured by NCI CTC version 3.0;   Objective tumor response as measured by monthly physical exam and radiographic evaluation every 12 weeks
6 Recruiting Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis
Condition: Chronic Stable Plaque Psoriasis
Interventions: Drug: Clobex Spray;   Drug: Vectical Ointment;   Procedure: Excimer Laser
Outcome Measures: The primary endpoint will be the percentage of patients achieving PASI-75 response at week 12.;   The secondary endpoint will be the percentage of patients achieving PASI-75 at weeks 4 and 8.;   A tertiary endpoint will be the percentage of patients achieving PASI-90 at weeks 4, 8, and 12.
7 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.
8 Unknown  Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients
Condition: Proteinuria
Interventions: Drug: Calcitriol;   Drug: Placebo
Outcome Measures: Changes in proteinuria;   Changes in renal function;   Changes in urinary renal damage markers
9 Recruiting PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
Intervention: Drug: Calcitriol 3 mcg/g ointment
Outcome Measures: C max of calcitriol plasma level;   C min of calcitriol plasma level;   T max of calcitriol plasma level;   AUC of calcitriol plasma level;   Calcium homeostasis parameters
10 Not yet recruiting Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
Conditions: Chronic Kidney Disease;   Proteinuria
Intervention: Drug: Calcitriol
Outcome Measures: the percentage change of proteinuia;   the proportion of patients achieving at least a 15% decrease in proteinuria
11 Recruiting Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for Advanced or Recurrent Disease
Conditions: Breast Cancer;   Cervical Cancer;   Endometrial Cancer;   Ovarian Cancer;   Primary Peritoneal Carcinoma;   Bone Sarcoma;   Cancer;   Solid Tumor
Intervention: Drug: compound 31543 Calcitriol
Outcome Measures: Determine Maximum Tolerated Dose (MTD) of Topical Compound 31543;   record and observe adverse events in patient use of topical compound 31543 to determine overall Safety and tolerability;   Observe and determine potential efficacy of topical calcitriol
12 Recruiting The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
Condition: Systemic Lupus Erythematosus
Interventions: Drug: calcitriol;   Drug: placebo
Outcome Measures: change in proteinuria;   risk of lupus flare;   change in renal function;   change in serum inflammatory markers;   change in Systemic Lupus Erythematosus Disease Activity Index score
13 Not yet recruiting Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Psoriasis Vulgaris
Intervention: Drug: Calcitriol
Outcome Measure: Laboratory parameters related to calcium metabolism after 26 weeks of topical treatment with Calcitriol 3 mcg/g
14 Recruiting Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Conditions: Arterial Dysfunction;   Chronic Kidney Disease
Interventions: Drug: Cholecalciferol;   Drug: Calcitriol
Outcome Measures: Difference between the calcitriol and cholecalciferol groups in conduit artery endothelium-dependent dilation (EDD) in response to treatment.;   To compare the efficacy of calcitriol and cholecalciferol supplementation on plasma concentrations of C-reactive protein;   To compare the effect of calcitriol and cholecalciferol supplementation on vascular endothelial cell expression of Nf-kB
15 Recruiting Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
Conditions: Lung Cancer;   Precancerous Condition;   Tobacco Use Disorder
Interventions: Drug: calcitriol;   Other: laboratory biomarker analysis;   Other: pharmacological study
Outcome Measure: Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks
16 Unknown  Calcitriol in the Treatment of Immunoglobulin A Nephropathy
Conditions: Glomerulonephritis;   Autoimmune Diseases
Intervention: Drug: Calcitriol
Outcome Measure: decline of urine protein
17 Recruiting The VALDIATE-D Study
Conditions: Type 2 Diabetes;   Obesity
Interventions: Drug: Calcitriol and Lisinopril;   Drug: Placebo
Outcome Measures: Circulating RAS activity after calcitriol/placebo therapy;   Renal-vascular tissue RAS activity after calcitriol/placebo therapy;   Renal-vascular RAS activity and urien protein after calcitriol/lisinopril therapy;   Adiponectin levels;   Adipose-tissue RAS measures
18 Recruiting Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
Condition: IgA Nephropathy
Intervention: Drug: Calcitriol
Outcome Measures: changes in proteinuria;   changes in serum creatinine;   changes in systolic blood pressure and diastolic pressure;   changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha);   changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone;   changes in serum inflammatory markers (hsCRP, IL-6)
19 Recruiting Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease
Conditions: Chronic Kidney Disease;   Anemia of Chronic Disease
Interventions: Drug: Oral Calcitriol 0.5 mcg once daily for 6 weeks;   Drug: Placebo
Outcome Measures: Change in serum hepcidin levels;   Change in soluble hemojuvelin;   Change in other indices of iron metabolism;   Change in serum hemoglobin
20 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

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

A major focus of Calcijex 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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