Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
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ClinicalTrials.gov Identifier: NCT00048438 |
Recruitment Status :
Completed
First Posted : November 4, 2002
Last Update Posted : August 15, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Insufficiency, Chronic | Drug: paricalcitol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly) |
Study Start Date : | February 2002 |

- The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Under care of physician at least 2 months (for CKD)
- Not on active Vitamin D therapy for at least 4 weeks prior
-
If female:
- Not of childbearing potential, OR
- Practicing birth control
- Not breastfeeding
- If taking phosphate binders, on a stable regimen at least 4 weeks prior
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For entry into Pretreatment Phase:
- iPTH at least 120 pg/mL
- GFR of 15-60 mL/min and no dialysis expected for at least 6 months
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For entry into Treatment Phase:
- Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL
- 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
- 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL
Exclusion Criteria:
- History of allergic reaction or sensitivity to similar drugs
- Acute Renal Failure within 12 weeks of study
- Chronic gastrointestinal disease
- Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones
- Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
- Current malignancy, or clinically significant liver disease
- Active granulomatous disease (TB, sarcoidosis, etc.)
- History of drug or alcohol abuse within 6 mos. prior
- Evidence of poor compliance with diet or medication
- Received any investigational drug or participated in any device trial within 30 days prior
- Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
- On glucocorticoids for a period of more than 14 days within the last 6 months
- HIV positive

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048438

Study Director: | Laura Williams, M.D. | Abbott |
ClinicalTrials.gov Identifier: | NCT00048438 |
Other Study ID Numbers: |
2001-019 |
First Posted: | November 4, 2002 Key Record Dates |
Last Update Posted: | August 15, 2006 |
Last Verified: | August 2006 |
Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Urologic Diseases |