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Kidney InsufficiencyTOPNCT01083849

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

An observational study of Kidney Insufficiency and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott) at 87 sites in 2 countries.

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 purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. Read more about this study

Who is it for?
Ages 18 years and older
How many people
761 participants
Where
87 sitesin 2 countries
Study dates
Mar 2008to Dec 2013
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: Participating sites were facilities specialized in the treatment of chronic kidney disease and offices of community-based specialists/nephrologists in Germany and Austria.

Who may be able to join

  • The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease
  • Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study

Who cannot join

  • The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply
  • An additional exclusion criterion is a parathyroid hormone- value of > 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol

Trial locations and contacts

87 sites in 2 countries.

87 sites in 2 countries

Germany76 sites

  • Site Reference ID/Investigator# 28352

    Aachen, 52066

  • Site Reference ID/Investigator# 28359

    Alsfeld, 36304

  • Site Reference ID/Investigator# 28305

    Arnstadt, 99310

  • Site Reference ID/Investigator# 28306

    Aschersleben, 06449

  • Site Reference ID/Investigator# 28003

    Augsburg, 86154

  • Site Reference ID/Investigator# 81613

    Aurich, 26605

  • Site Reference ID/Investigator# 28017

    Bad Bevensen, 29549

  • Site Reference ID/Investigator# 28301

    Bad Nenndorf, 31542

  • Site Reference ID/Investigator# 28296

    Balingen, 72336

  • Site Reference ID/Investigator# 28021

    Berlin, 10785

  • Site Reference ID/Investigator# 28024

    Berlin, 12435

  • Site Reference ID/Investigator# 28303

    Berlin, 12627

  • Site Reference ID/Investigator# 54050

    Berlin, 14193

  • Site Reference ID/Investigator# 28022

    Bernburg, 06406

  • Site Reference ID/Investigator# 30862

    Betzdorf, 57518

  • Site Reference ID/Investigator# 28007

    Bielefeld, 33609

  • Site Reference ID/Investigator# 28304

    Burg, 39288

  • Site Reference ID/Investigator# 28014

    Coburg, 96450

  • Site Reference ID/Investigator# 28023

    Cottbus, 03046

  • Site Reference ID/Investigator# 28134

    Demmin, 17109

  • Site Reference ID/Investigator# 28037

    Dresden, 01217

  • Site Reference ID/Investigator# 43903

    Dresden, 01307

  • Site Reference ID/Investigator# 99777

    Elmshorn, 25337

  • Site Reference ID/Investigator# 28284

    Elsenfeld, 63820

  • Site Reference ID/Investigator# 124118

    Emden, 26721

  • Site Reference ID/Investigator# 54054

    Emsdetten, 48282

  • Site Reference ID/Investigator# 48864

    Erfurt, 99089

  • Site Reference ID/Investigator# 72343

    Erkelenz, 41812

  • Site Reference ID/Investigator# 28029

    Eschweiler, 52249

  • Site Reference ID/Investigator# 28287

    Friedrichroda, 99894

  • Site Reference ID/Investigator# 28276

    Gera, 07548

  • Site Reference ID/Investigator# 28351

    Halle, 06118

  • Site Reference ID/Investigator# 28280

    Hamburg, 22767

  • Site Reference ID/Investigator# 48865

    Hanover, 30625

  • Site Reference ID/Investigator# 28300

    Heilbronn, 74076

  • Site Reference ID/Investigator# 28011

    Herford, 32049

  • Site Reference ID/Investigator# 124119

    Herne, 44623

  • Site Reference ID/Investigator# 28019

    Herzberg, 04916

  • Site Reference ID/Investigator# 28135

    Hildesheim, 31134

  • Site Reference ID/Investigator# 28286

    Hoyerswerda, 02977

  • Site Reference ID/Investigator# 28353

    Ilfeld, 99768

  • Site Reference ID/Investigator# 28044

    Jena, 07743

  • Site Reference ID/Investigator# 48863

    Kiel, 24106

  • Site Reference ID/Investigator# 28013

    Lahr, 77933

  • Site Reference ID/Investigator# 28025

    Loerrach, 79539

  • Site Reference ID/Investigator# 28290

    Ludwigslust, 19288

  • Site Reference ID/Investigator# 10982

    Magdeburg, 39108

  • Site Reference ID/Investigator# 28291

    Malente, 23714

  • Site Reference ID/Investigator# 28036

    Mannheim, 68309

  • Site Reference ID/Investigator# 28302

    Marburg, 35043

  • Site Reference ID/Investigator# 54051

    Minden, 32429

  • Site Reference ID/Investigator# 28278

    Müllheim, 79379

  • Site Reference ID/Investigator# 99778

    Munich, 80336

  • Site Reference ID/Investigator# 99776

    Neumünster, 24534

  • Site Reference ID/Investigator# 124120

    Nordhorn, 48527

  • Site Reference ID/Investigator# 28275

    Nordhorn, 48529

  • Site Reference ID/Investigator# 43904

    Oberstdorf, 87561

  • Site Reference ID/Investigator# 28277

    Osnabrück, 49074

  • Site Reference ID/Investigator# 28297

    Peine, 31224

  • Site Reference ID/Investigator# 28307

    Pirmasens, 66953

  • Site Reference ID/Investigator# 28295

    Potsdam, 14482

  • Site Reference ID/Investigator# 28294

    Quedlinburg, 06484

  • Site Reference ID/Investigator# 48862

    Rendsburg, 24768

  • Site Reference ID/Investigator# 28042

    Ribnitz-Damgarten, 18311

  • Site Reference ID/Investigator# 28282

    Rostock, 18107

  • Site Reference ID/Investigator# 28033

    Saint Wendel, 66606

  • Site Reference ID/Investigator# 54052

    Stuttgart, 70199

  • Site Reference ID/Investigator# 28005

    Stuttgart, 70376

  • Site Reference ID/Investigator# 28020

    Viersen, 41751

  • Site Reference ID/Investigator# 28293

    Villingen-Schwenningen, 78054

  • Site Reference ID/Investigator# 28018

    Völklingen, 66333

  • Site Reference ID/Investigator# 28298

    Weißenfels, 06667

  • Site Reference ID/Investigator# 28292

    Wetzlar, 35578

  • Site Reference ID/Investigator# 48882

    Wiesbaden, 65191

  • Site Reference ID/Investigator# 28299

    Wolfenbüttel, 38304

  • Site Reference ID/Investigator# 28279

    Zwickau, 08056

Other trials in Germany

Austria11 sites

  • Site Reference ID/Investigator# 64522

    Feldkirch, 6800

  • Site Reference ID/Investigator# 53506

    Graz, 8010

  • Site Reference ID/Investigator# 53524

    Graz, 8036

  • Site Reference ID/Investigator# 74733

    Innsbruck, 6020

  • Site Reference ID/Investigator# 64523

    Rottenmann, 8786

  • Site Reference ID/Investigator# 53525

    Salzburg, 5020

  • Site Reference ID/Investigator# 53526

    Sankt Pölten, 3100

  • Site Reference ID/Investigator# 69662

    Steyr, 4400

  • Site Reference ID/Investigator# 53508

    Vienna, 1090

  • Site Reference ID/Investigator# 53523

    Vienna, 1130

  • Site Reference ID/Investigator# 53507

    Vienna, 1220

Other trials in Austria

About this study

Official title: Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Read the detailed description

According to protocol amendment of 16 October 2010 Austria is participating in this study.

Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis.

Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.

Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Keywords
Observational study, Paricalcitol, Treatment of Hyperparathyroidism, Chronic kidney disease stage 3, 4 and 5 (CKD stage 3, 4 and 5), Chronic Kidney Disease, Zemplar, sHPT, Secondary
Medical subject headings
Renal Insufficiency, Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Neoplasm Metastasis

What participants receive

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

Study groups in NCT01083849
Study groupRoleWhat they receive
ParicalcitolParticipants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

What is being measured

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

  1. Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

    Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).

    Measured: Up to 12 Months

  2. Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months

    Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).

    Measured: Up to 12 months

Secondary outcomes (7)

  1. Number of Participants With Hypercalcemia

    Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.

    Measured: Months 0, 3, 6, 9, and 12

  2. Number of Participants With Hyperphosphatemia

    Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.

    Measured: Months 0, 3, 6, 9, and 12

  3. Number of Participants With Elevated Calcium-Phosphorus Product

    Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.

    Measured: Months 0, 3, 6, 9, and 12

  4. Mean Duration of Hospitalization by Visit

    Measured: Months 0, 3, 6, 9, and 11

  5. Mean Duration of Disability by Visit

    Measured: Months 0, 3, 6, 9, and 11

  6. Mean Intact Parathormone (iPTH) Levels by Visit

    Measured: Months 0, 3, 6, 9, and 12

  7. Mean Calcium-Phosphate Product Levels by Visit

    Measured: Months 0, 3, 6, 9, and 12

Timeline

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

  1. First posted10 Mar 2010 (estimated)
  2. Study startMar 2008
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
761 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01083849
Sponsor's protocol ID
P10-681
Acronym
TOP
Status last verified
Dec 2014
First submitted
25 Feb 2010
Last updated
19 Dec 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Insufficiency and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott) at 87 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 2 inclusion and 2 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 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Germany, Austria. 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 19 Dec 2014). 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?

Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months (time frame: Up to 12 Months). 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 NCT01083849.

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 19 Dec 2014.

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