Kidney Failure, ChronicNCT01273597

Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

An observational study of Kidney Failure, Chronic, run by AbbVie (prior sponsor, Abbott) at 11 sites in Hungary.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic
How many people: 60 participants
Where: 11 sitesHungary
Study dates: Jan 2011to Nov 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: Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary

Who may be able to join

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
≥ 18 years of age,
Willing to sign the patient information and informed consent form,
Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
higher than 800 pg/mL and parathyroidectomy is contraindicated.
The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Who cannot join

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
The patient is already treated with Zemplar (paricalcitol injection),
Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
Patients who decline to participate in the study or decline to sign the patient information/informed consent form.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Hungary11 sites

Site Reference ID/Investigator# 46593
Budapest, 1083
Site Reference ID/Investigator# 46585
Budapest, 1115
Site Reference ID/Investigator# 46594
Debrecen, 4012
Site Reference ID/Investigator# 47722
Győr, 9023
Site Reference ID/Investigator# 46592
Karcag, 5301
Site Reference ID/Investigator# 58644
Karcag, 5301
Site Reference ID/Investigator# 46595
Miskolc, 3501
Site Reference ID/Investigator# 46588
Nyíregyháza, 4400
Site Reference ID/Investigator# 46597
Pécs, 7624
Site Reference ID/Investigator# 46590
Szombathely, 9700
Site Reference ID/Investigator# 46591
Veszprém, 8200

Other trials in Hungary

About this study

Official title: Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary

This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.

Read the detailed description

Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.

Conditions: Kidney Failure, Chronic
Keywords: Parathyroid hormone,Kidney failure, chronic,Hyperparathyroidism, secondary
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Neoplasm Metastasis

What participants receive

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

Study groups in NCT01273597
Study group	Role	What they receive
End-stage kidney disease with secondary hyperparathyroidism		Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

What is being measured

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

Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
Measured: 6 months

Secondary outcomes (8)

Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
Measured: 6 months
Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Measured: 6 months prior to start of study through 6 months of treatment
Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Measured: 6 months prior to start of study through 6 months of treatment
Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Measured: 6 months prior to start of study through 6 months of treatment
Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
Measured: 6 months prior to start of study through baseline
Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
Measured: 6 months
Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
Measured: 6 months prior to start of study through baseline
Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
Measured: 6 months

Timeline

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

Jan 2011Nov 2011

First posted10 Jan 2011 (estimated)
Study startJan 2011
Primary completionNov 2011
Study completionNov 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 Kidney Failure, 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01273597
Sponsor's protocol ID: P12-644
Status last verified: Jan 2013
First submitted: 22 Nov 2010
Last updated: 18 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary
ClinicalTrials.gov ID: NCT01273597
Acronym / sponsor ID: P12-644
Conditions: Kidney Failure, Chronic
Keywords: Parathyroid hormone,Kidney failure, chronic,Hyperparathyroidism, secondary
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Planimeter Ltd
Study start: Jan 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 21 Dec 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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
End-stage kidney disease with secondary hyperparathyroidism	–	–Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary

Key inclusion criteria (7 listed)

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
≥ 18 years of age,
Willing to sign the patient information and informed consent form,
Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Key exclusion criteria (4 listed)

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
The patient is already treated with Zemplar (paricalcitol injection),
Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
Patients who decline to participate in the study or decline to sign the patient information/informed consent form.

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

Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Time frame: 6 months
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.

8 secondary outcomes

Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Time frame: 6 months
Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
Time frame: 6 months prior to start of study through 6 months of treatment
Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
Time frame: 6 months prior to start of study through 6 months of treatment
Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
Time frame: 6 months prior to start of study through 6 months of treatment
Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Time frame: 6 months prior to start of study through baseline
Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Time frame: 6 months
Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Time frame: 6 months prior to start of study through baseline
Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Time frame: 6 months

Results and safety

Results posted to the registry on 21 Dec 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
End-stage Kidney Disease With Secondary Hyperparathyroidism	60	52

Primary outcome: Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)

Time frame: 6 months. Mean (Standard Deviation). Unit: weeks

Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n = 16
Value	12.2 (7.6)

Population analysed: Participants who achieved maintenance dose of Zemplar (paricalcitol injection)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
End-stage Kidney Disease With Secondary Hyperparathyroidism	9 of 60 (15%)	16 of 60 (26.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Kidney Failure, Chronic

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RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
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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.

Tamas Schnaider study director

AbbVie (prior sponsor, Abbott)

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

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Failure, Chronic, run by AbbVie (prior sponsor, Abbott) at 11 sites in Hungary.

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 7 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 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Hungary. 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 21 Dec 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?

Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) (time frame: 6 months). 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 NCT01273597.

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 18 Jan 2013; AzTrials last refreshed its copy on 30 Oct 2026.