Secondary hyperparathyroidism (SHPT) MedDRA version: 12.0 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary MedDRA version: 12.0 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Trade Name: Zemplar
Product Name: paricalcitol
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Paricalcitol
CAS Number: 131918-61-1
Other descriptive name: PARICALCITOL
Concentration unit: µg
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible for study participation if he/she meets the following criteria: 1. Male or female patients = 18 years old. 2. Patient has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the patient has had the opportunity to ask questions. The informed consent must be signed prior to the conduct of any study-specific Screening procedures or withholding any medications. 3. Patient is diagnosed with Stage 5 CKD and has been receiving IV or oral vitamin D receptor activators (VDRAs) or cinacalcet during the 8 weeks prior to the Screening Period or naive patients that have not received VDRA therapy or cinacalcet within 8 weeks of Screening. 4. Patient is on maintenance HD (hemodialysis) TIW for at least 3 months prior to screening and is expected to remain on HD for the duration of the study. 5. For entry into the Pre-Treatment Washout Period (for patients that are not naïve to VDRAs and cinacalcet), the patient must have Screening laboratory values of: ? iPTH level 130 to 700 pg/mL inclusive ? Serum Total Alkaline Phosphatase level > 40 U/L ? Calcium level = 10.0 mg/dL (2.49 mmol/L) ? Ca×P = 75 mg2/dL2 (US) and = 70 mg2/dL2 (ex-US) For entry into Treatment Period (for patients that have completed the washout or that are naïve to VDRAs and cinacalcet), the patient must meet the following laboratory criteria prior to randomization: ? iPTH between 300 and 800 pg/mL inclusive ? Calcium level of 8.4 to 10.0 mg/dL inclusive (2.09 to 2.49 mmol/L) ? Phosphorus = 6.5 mg/dL (2.09 mmol/L) 6. If female, patient is not breastfeeding. 7. If female, patient must have a negative serum pregnancy test prior to the Treatment Period. 8. If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and practicing one of the following methods of birth control: ? Maintains a monogamous relationship with a vasectomized partner. ? Double barrier method (any two of the following: condoms, contraceptive sponge, diaphragm, vaginal ring with spermicidal jellies or creams or intrauterine device [IUD]). ? Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to and during study drug administration. ? Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from the study if he/she meets any of the following criteria: 1. Patient has a history of an allergic reaction or significant sensitivity to drugs similar to the study drugs (paricalcitol, cinacalcet, doxercalciferol [US sites], or alfacalcidol [Ex-US sites, including Russia]). 2. Patient is expected to need more than 2.0 grams of oral elemental calcium per day as total intake, which includes > 1.6 grams per day of elemental calcium as the phosphate binder. 3. Patient has a history of parathyroidectomy. 4. Patient has chronic gastrointestinal (GI) disease, which, in the opinion of the investigator, may result in clinically significant gastrointestinal malabsorption. 5. Patient has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, defined as =3 x the upper limit of normal (ULN) for serum glutamic-oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvic (SGPT/ALT) and total bilirubin as determined by medical history. 6. Patient has a history of drug or alcohol abuse that, in the opinion of the investigator, is thought to impact the patient's participation in the study. 7. Patient has evidence of poor compliance with diet, medication or HD that may interfere, in the opinion of the investigator, with adherence to the protocol. 8. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6 (CYP2D6) (e.g., flecainide, vinblastine, thioridazine and most tricyclic antidepressants) within 2 weeks prior to study drug administration. Commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by CYP2D6, thus, an adjustment to a lower dose may be required. 9. Patient has participated in any investigational study or received any investigational drug within 4 weeks prior to the Treatment Period. 10. Patient is known to be HIV positive. 11. For any reason, subject is considered by the investigator to be an unsuitable candidate to receive any of the study medications or is put at risk by study procedures. 12. Patient has any of the known contraindications of cinacalcet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the superiority of paricalcitol as compared to cinacalcet with supplemental low dose vitamin D therapy, as assessed by the proportion of haemodialysis subjects that achieve a mean iPTH value between 150 to 300 pg/mL during Weeks 21 to 28.;Secondary Objective: To evaluate the following: 1. The proportion of subjects achieving at least 30% reduction from baseline in iPTH as assessed by the mean iPTH obtained in Weeks 21 to 28. 2. The proportion of subjects achieving at least 50% reduction from baseline in iPTH as assessed by the mean iPTH obtained in Weeks 21 to 28. 3. The change from baseline in iPTH, calcium and calcium-phosphorus product as assessed by the mean values obtained in Weeks 21 to 28. 4. The proportion of subjects with calcium 10.5 mg/dL (2.61 mmol/L) as assessed by the mean calcium obtained in Weeks 21 to 28.;Primary end point(s): The primary efficacy endpoint is the proportion of subjects that achieve a mean iPTH value between 150 to 300 pg/mL during Weeks 21 to 28 of the Treatment Period. | — |
Countries
Czech Republic, Denmark, Germany, Greece, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed