End Stage Renal DiseasePhase 3NCT00646035
A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
A Phase 3 study testing paricalcitol capsules in people with End Stage Renal Disease, run by Abbott at 24 sites in 2 countries.
Trial summary
To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- paricalcitol capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Jan 2002to Nov 2002
- 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
- Subject is greater than or equal to 18 years.
- Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.
- If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.
- If female, subject must have a negative serum pregnancy test prior to treatment.
- If female, subject is not breastfeeding.
- Subject is undergoing full PD regimen and is expected to remain on this PD regimen for the duration of the study.
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- For those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the Pre-Treatment Phase.
- For entry into the Pretreatment Phase the subject must have: Calcium level less than or equal to 10.5 mg/dL and Ca x P level less than or equal to 65.
- For entry into the Treatment Phase the subject must have: iPTH greater than or equal to 300 pg/mL, calcium level of 8.0 to 10.5 mg/dL, inclusive, and Ca x P less than or equal to 65.
- Subject has voluntarily signed and dated an IRB approved informed consent.
Who cannot join
- Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug
- Subject has had active peritonitis within 1 month prior to screening phase.
- Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
- Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
- Subject has had acute renal failure within 3 months of screening phase.
- Subject has chronic gastrointestinal disease.
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- Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.
- Subject has a current malignancy or clinically significant liver disease.
- Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.
- Subject has evidence of poor compliance with diet, medication, or PD.
- Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.
- Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
- For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.
- Subject is known to be HIV positive.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States22 sites
Study site
Charleston, South Carolina, 29425
Study site
Cincinnati, Ohio, 45206
Study site
Cincinnati, Ohio, 45220
Study site
Cleveland, Ohio, 44195
Study site
Denver, Colorado, 80230
Study site
Evanston, Illinois, 60201
Study site
Fort Myers, Florida, 33919
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Las Vegas, Nevada, 89102
Study site
Los Angeles, California, 90095
Study site
Lubbock, Texas, 79430
Study site
Maywood, Illinois, 60153
Study site
Memphis, Tennessee, 38105
Study site
Mineola, New York, 11501
Study site
Nashville, Tennessee, 37205
Study site
New Orleans, Louisiana, 70112
Study site
Portland, Oregon, 97210
Study site
Savannah, Georgia, 31405
Study site
St Louis, Missouri, 63110
Study site
Tampa, Florida, 33603
Study site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.
- Conditions
- End Stage Renal Disease
- Being tested
- paricalcitol capsules
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitol capsulesDrug
Also called ABT-358, Zemplar, paricalcitol
baseline iPTH/60
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: paricalcitol capsules |
| B | Placebo comparator | Not described Receives: Drug: paricalcitol capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels.
Measured: 12 weeks
The incidence of clinically meaningful hypercalcemia and elevated Ca x P.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startJan 2002
- Primary completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646035
- Sponsor's protocol ID
- 2001-015
- Other IDs
- R&D/02/655
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00646035
- Acronym / sponsor ID
- 2001-015
- Conditions
- End Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Nov 2002 (actual)
- First posted
- 28 Mar 2008 (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.
To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: paricalcitol capsules |
| B | Placebo comparator | Drug: paricalcitol capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is greater than or equal to 18 years.
- Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.
- If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.
- If female, subject must have a negative serum pregnancy test prior to treatment.
- If female, subject is not breastfeeding.
Key exclusion criteria (14 listed)
- Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug
- Subject has had active peritonitis within 1 month prior to screening phase.
- Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
- Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
- Subject has had acute renal failure within 3 months of screening phase.
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 capsulesAlso: ABT-358, Zemplar, paricalcitolbaseline iPTH/60 | Drug | A, B |
Primary outcome
The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels.
Time frame: 12 weeks
The incidence of clinically meaningful hypercalcemia and elevated Ca x P.
Time frame: 12 weeks
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 28 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 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 capsules in people with End Stage Renal Disease, run by Abbott at 24 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 10 inclusion and 14 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 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. Some participants in this study may receive a placebo. 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 achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 28 Mar 2008.