Chronic Kidney FailureNCT01081665

Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

An observational study of Chronic Kidney Failure and Secondary Hyperparathyroidism, run by Abbott at 19 sites in Greece.

Completed

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

Official record

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Trial summary

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Failure, Secondary Hyperparathyroidism
Type of treatment: Injection or infusion
How many people: 237 participants
Where: 19 sitesGreece
Study dates: Dec 2006to Feb 2011
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

Who may be able to join

Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
Subject is receiving chronic hemodialysis.
Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
Subject has provided their informed consent to participate.

Who cannot join

Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
Subject has participated in clinical study within the last month.
Zemplar is contraindicated according to the Summary of Product Characteristics.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Greece19 sites

Site Reference ID/Investigator# 32055
Athens, 11526
Site Reference ID/Investigator# 32050
Athens, 11528
Site Reference ID/Investigator# 32051
Athens, 11528
Site Reference ID/Investigator# 32049
Athens, 17237
Site Reference ID/Investigator# 5283
Athens
Site Reference ID/Investigator# 32056
Chalcis, 34100
Site Reference ID/Investigator# 32057
Chania, 73100
Site Reference ID/Investigator# 32077
Cholargós, 15562
Site Reference ID/Investigator# 32058
Drama, 66100
Site Reference ID/Investigator# 32076
Katerini, 60100
Site Reference ID/Investigator# 32059
Kavala, 65201
Site Reference ID/Investigator# 32053
Komotini, 69100
Site Reference ID/Investigator# 32060
Lamia, 35100
Site Reference ID/Investigator# 32061
Lefkada, 31100
Site Reference ID/Investigator# 32062
Livadia, 32100
Site Reference ID/Investigator# 32048
Piraeus
Site Reference ID/Investigator# 32054
Preveza, 48100
Site Reference ID/Investigator# 32063
Ptolemaida, 50200
Site Reference ID/Investigator# 32075
Volos, 38222

Other trials in Greece

About this study

Official title: A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

Read the detailed description

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

40% reduction in the base iPTH level is achieved, and/or;
serum iParathormone level < 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Conditions: Chronic Kidney Failure, Secondary Hyperparathyroidism
Keywords: Chronic Kidney Failure, Secondary Hyperparathyroidism, Paricalcitol IV treatment, Safety and efficacy assessment
Medical subject headings: Kidney Failure, Chronic, Hyperparathyroidism, Secondary

What participants receive

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

Study groups in NCT01081665
Study group	Role	What they receive
Chronic Kidney Disease		All eligible patients treated with IV Paricalcitol (Zemplar)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
Measured: Baseline to Month 24 Visit
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
The mean (average) number of days hospitalized per participant for those hospitalized during the study.
Measured: Baseline to Month 24 Visit

Secondary outcomes (5)

The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.
Measured: Baseline to Month 24 Visit
The Incidence of Clinically Significant Hypercalcemia
The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
Measured: Baseline to Month 24 Visit
The Incidence of Clinically Significant Hyperphosphatemia
The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
Measured: Baseline to Month 24 Visit
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.
Measured: Baseline to Month 24 Visit
To Estimate the Incidence of (S)AEs/(S)ADRs
The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.
Measured: Baseline to Month 24 Visit

Timeline

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

Dec 2006Feb 2011

First posted5 Mar 2010 (estimated)
Study startDec 2006
Primary completionFeb 2011
Study completionFeb 2011

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 FailureStudies 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: Observational
Time perspective: Prospective
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01081665
Sponsor's protocol ID: P06-120
Status last verified: Mar 2012
First submitted: 27 Feb 2010
Last updated: 27 Mar 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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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism
ClinicalTrials.gov ID: NCT01081665
Acronym / sponsor ID: P06-120
Conditions: Chronic Kidney Failure, Secondary Hyperparathyroidism
Keywords: Chronic Kidney Failure, Secondary Hyperparathyroidism, Paricalcitol IV treatment, Safety and efficacy assessment
Study type: Observational
Recruitment status: Completed
Enrolment: 237 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 5 Mar 2010 (estimated)
Results: Posted 12 Mar 2012

Clinical summary

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

Detailed description

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

40% reduction in the base iPTH level is achieved, and/or;
serum iParathormone level < 300 pg/mL.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic Kidney Disease	–	–All eligible patients treated with IV Paricalcitol (Zemplar)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

Key inclusion criteria (4 listed)

Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
Subject is receiving chronic hemodialysis.
Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
Subject has provided their informed consent to participate.

Key exclusion criteria (4 listed)

Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
Subject has participated in clinical study within the last month.
Zemplar is contraindicated according to the Summary of Product Characteristics.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Time frame: Baseline to Month 24 Visit
The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
Time frame: Baseline to Month 24 Visit
The mean (average) number of days hospitalized per participant for those hospitalized during the study.

5 secondary outcomes

The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
Time frame: Baseline to Month 24 Visit
The Incidence of Clinically Significant Hypercalcemia
Time frame: Baseline to Month 24 Visit
The Incidence of Clinically Significant Hyperphosphatemia
Time frame: Baseline to Month 24 Visit
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
Time frame: Baseline to Month 24 Visit
To Estimate the Incidence of (S)AEs/(S)ADRs
Time frame: Baseline to Month 24 Visit

Results and safety

Results posted to the registry on 12 Mar 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
Chronic Kidney Disease	237	142

Primary outcome: Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations

Time frame: Baseline to Month 24 Visit. Number. Unit: participants

Measure	Chronic Kidney Disease n = 237
Participants with no hospitalizations	152
Participants with at least 1 hospitalization	85
>Participants with 1 hospitalization	59
>Participants with 2 hospitalizations	16
>Participants with 3 or more hospitalizations	10

Population analysed: Analysis included all enrolled participants.

Primary outcome: Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized

Time frame: Baseline to Month 24 Visit. Mean (Standard Deviation). Unit: days

Measure	Chronic Kidney Disease n = 82
Value	16.1 (17.5)

Population analysed: Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Kidney Disease	94 of 237 (39.7%)	170 of 237 (71.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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.

Konstantinos Xynos, MD study chair

Abbott Laboratories Hellas S.A.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Failure and Secondary Hyperparathyroidism, run by Abbott at 19 sites in Greece.

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 4 inclusion and 4 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 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Greece. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 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?

Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations (time frame: Baseline to Month 24 Visit). 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?

On the ClinicalTrials.gov record for NCT01081665.

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 27 Mar 2012.