Renal Insufficiency, ChronicPhase 3NCT00048438
Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
A Phase 3 study testing paricalcitol in people with Renal Insufficiency, Chronic, run by Abbott at 18 sites in 2 countries.
Trial summary
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- paricalcitol
- How many people
- 68 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Feb 2002to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- If taking phosphate binders, on a stable regimen at least 4 weeks prior
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Northwestern University Medical School
Chicago, Illinois, 60611
Kidney and Hypertension Center
Cincinnati, Ohio, 45220
University of Missouri Health Sciences Center
Columbia, Missouri, 65212
Dorn VA Hospital
Columbia, South Carolina, 29209
Dallas Nephrology Associates
Dallas, Texas, 75235
North Shore University Hospital
Great Neck, New York, 11021
Outcomes Research International, Inc.
Hudson, Florida, 34667
Arms, Dodge, Robinson, Wilber and Crouch
Kansas City, Missouri, 64111
NEA Research
Las Vegas, Nevada, 89102
Nephrology Association of South Miami
Miami, Florida, 33173
Mount Sinai School of Medicine
New York, New York, 10029
UCI Medical Center
Orange, California, 92868
Wake Nephrology Associates, PA
Raleigh, North Carolina, 27609
Washington University School of Medicine
St Louis, Missouri, 63110
Tampa Bay Nephrology Associates
Tampa, Florida, 33603
Western Nephrology
Thornton, Colorado, 80260
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, 98644
About this study
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- paricalcitol
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2002 (estimated)
- Study startFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 68 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laura Williams, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048438
- Sponsor's protocol ID
- 2001-019
- Status last verified
- Aug 2006
- First submitted
- 31 Oct 2002
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
- ClinicalTrials.gov ID
- NCT00048438
- Acronym / sponsor ID
- 2001-019
- Conditions
- Renal Insufficiency, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- First posted
- 4 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Under care of physician at least 2 months (for CKD)
- Not on active Vitamin D therapy for at least 4 weeks prior
- If female:
- If taking phosphate binders, on a stable regimen at least 4 weeks prior
- For entry into Pretreatment Phase:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paricalcitol | Drug | – |
Primary outcome
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Williams, M.D. study director
Abbott
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paricalcitol in people with Renal Insufficiency, Chronic, run by Abbott at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2006.