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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Ergocalciferols; Hormones

Criteria

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.