Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

All Conditions

Neoplasms

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Hypercalcemia

Neoplastic Processes

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Parathyroid Diseases

Endocrine System Diseases

Chronic Disease

Disease Attributes

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Vitamins

Hormones

Parathyroid Hormone

Ergocalciferols

Calcium

Calcium, Dietary

Trace Elements

Calciferol

Ergocalciferol

Vitamin D2

Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.

Zemplar (paricalcitol)

Oscar E Guerra, MD

The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.

Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

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

The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.

Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.

The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter \[mg/dL\]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.

Abbott

The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.

Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.

Paricalcitol Injection

Age Continuous

Sex: Female, Male

Peru

Region of Enrollment

Global Medical Services

Analysis is based on the number of participants completing the study.

The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL

Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL

Hyperphosphatemia

Elevation of Ca x P product

Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).

Overall Study

Spots Global Cancer Trial Database for Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial