Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Abbott

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: paricalcitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071070

M06-823

Details and patient eligibility

About

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Full description

Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Enrollment: 216 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is a Chinese male or female greater than or equal to 20 years old.

2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.

3. For entry into the Treatment Phase, the subject must have:

   • Intact parathyroid hormone greater than or equal to 300 pg/mL
   • Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
   • Calcium-phosphorus product less than 65 mg^2/dL^2

Exclusion criteria

1. Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
2. Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
3. Subject with New York Heart Association (NYHA) Class III or IV.
4. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
5. Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
6. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
7. Subject is known to be human immunodeficiency virus (HIV) positive.
8. Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).

Treatment:

Drug: paricalcitol

Group 2

Active Comparator group

Description:

Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)

Treatment:

Drug: paricalcitol