Chronic Kidney DiseasePhase 3NCT01071070

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

A Phase 3 study testing paricalcitol in people with Chronic Kidney Disease, run by Abbott at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: paricalcitol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 12 sitesChina
Study dates: Nov 2009to Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
Subject with New York Heart Association (NYHA) Class III or IV.
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.
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.
Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
Subject is known to be human immunodeficiency virus (HIV) positive.
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 locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

China12 sites

Site Reference ID/Investigator# 23483
Beijing, 100034
Site Reference ID/Investigator# 23485
Beijing, 100044
Site Reference ID/Investigator# 23482
Beijing, 100730
Site Reference ID/Investigator# 23484
Dalian, 116011
Site Reference ID/Investigator# 23486
Guangzhou, 510080
Site Reference ID/Investigator# 23488
Nanjing, 210029
Site Reference ID/Investigator# 37722
Qingdao, 266003
Site Reference ID/Investigator# 23490
Shanghai, 200001
Site Reference ID/Investigator# 25502
Shanghai, 200001
Site Reference ID/Investigator# 23489
Shanghai, 200025
Site Reference ID/Investigator# 23487
Shanghai, 200092
Site Reference ID/Investigator# 35822
Wenzhou, 325000

Other trials in China

About this study

Official title: A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis

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

Read the detailed 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.

Conditions: Chronic Kidney Disease
Being tested: paricalcitol
Keywords: Chronic Kidney Disease, Secondary hyperparathyroidism
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

paricalcitolDrug
Also called ABT-358, Zemplar
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.

Study groups in NCT01071070
Study group	Role	What they receive
Group 1	Active comparator	Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). Receives: Drug: paricalcitol
Group 2	Active comparator	Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg) Receives: Drug: paricalcitol

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 Intact Parathyroid Hormone Levels
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Measured: Baseline to 12 Weeks

Secondary outcomes (8)

The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
Measured: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
Measured: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium
Measured: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium-phosphorus Product
Measured: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
Measured: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
Measured: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
Measured: Baseline to 12 Weeks
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Nov 2010

First posted19 Feb 2010 (estimated)
Study startNov 2009
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney 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: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01071070
Sponsor's protocol ID: M06-823
Status last verified: Dec 2011
First submitted: 25 Nov 2009
Last updated: 26 Jan 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis
ClinicalTrials.gov ID: NCT01071070
Acronym / sponsor ID: M06-823
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease, Secondary hyperparathyroidism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 19 Feb 2010 (estimated)
Results: Posted 26 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Drug: paricalcitolInitial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Group 2	Active comparator	Drug: paricalcitolDose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject is a Chinese male or female greater than or equal to 20 years old.
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.
For entry into the Treatment Phase, the subject must have:

Key exclusion criteria (8 listed)

Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
Subject with New York Heart Association (NYHA) Class III or IV.
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.
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.

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
paricalcitolAlso: ABT-358, ZemplarInitiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.	Drug	Group 1, Group 2

Primary outcome

The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
Time frame: Baseline to 12 Weeks
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values

8 secondary outcomes

The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium-phosphorus Product
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
Time frame: Baseline to 12 Weeks
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
Time frame: Baseline to 12 weeks

Results and safety

Results posted to the registry on 26 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	108	104
Group 2	108	105

Primary outcome: The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels

Time frame: Baseline to 12 Weeks. Number. Unit: participants

Measure	Group 1 n = 105	Group 2 n = 102
Yes	93	57
No	12	45

Population analysed: The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of study drug administration until 30 days following discontinuation of study drug administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 108 (0%)	29 of 108 (26.9%)	Not reported
Group 2	3 of 108 (2.8%)	19 of 108 (17.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
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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.

Yue Kang, MD study director

Abbott (China)

12 sites in 1 country: 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 Chronic Kidney Disease, run by Abbott at 12 sites in China.

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 6 inclusion and 8 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. 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?

Yes. Results are posted in the registry (first posted 26 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Intact Parathyroid Hormone Levels (time frame: Baseline to 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01071070.

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 26 Jan 2012.