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

NCT01083849 | Completed Results

• 1 other identifier: P10-681
• Study Type: observational
• Target: 761
• Locations: 2 countries
• Sites: 87

Brief 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. 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.

Conditions

Kidney Insufficiency; Secondary Hyperparathyroidism

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

Outcome Measures

Primary Outcomes (2)

• 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).

  Up to 12 Months

• 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).

  Up to 12 months

Secondary Outcomes (7)

• Number of Participants With Hypercalcemia

  Months 0, 3, 6, 9, and 12

• Number of Participants With Hyperphosphatemia

  Months 0, 3, 6, 9, and 12

• Number of Participants With Elevated Calcium-Phosphorus Product

  Months 0, 3, 6, 9, and 12

• Mean Duration of Hospitalization by Visit

  Months 0, 3, 6, 9, and 11

• Mean Duration of Disability by Visit

  Months 0, 3, 6, 9, and 11

Study Arms (1)

Paricalcitol

Participants 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (87)

Site Reference ID/Investigator# 64522

Feldkirch, 6800, Austria

Location

Site Reference ID/Investigator# 53506

Graz, 8010, Austria

Location

Site Reference ID/Investigator# 53524

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 74733

Innsbruck, 6020, Austria

Location

Site Reference ID/Investigator# 64523

Rottenmann, 8786, Austria

Location

Site Reference ID/Investigator# 53525

Salzburg, 5020, Austria

Location

Site Reference ID/Investigator# 53526

Sankt Pölten, 3100, Austria

Location

Site Reference ID/Investigator# 69662

Steyr, 4400, Austria

Location

Site Reference ID/Investigator# 53508

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 53523

Vienna, 1130, Austria

Location

Site Reference ID/Investigator# 53507

Vienna, 1220, Austria

Location

Site Reference ID/Investigator# 28352

Aachen, 52066, Germany

Location

Site Reference ID/Investigator# 28359

Alsfeld, 36304, Germany

Location

Site Reference ID/Investigator# 28305

Arnstadt, 99310, Germany

Location

Site Reference ID/Investigator# 28306

Aschersleben, 06449, Germany

Location

Site Reference ID/Investigator# 28003

Augsburg, 86154, Germany

Location

Site Reference ID/Investigator# 81613

Aurich, 26605, Germany

Location

Site Reference ID/Investigator# 28017

Bad Bevensen, 29549, Germany

Location

Site Reference ID/Investigator# 28301

Bad Nenndorf, 31542, Germany

Location

Site Reference ID/Investigator# 28296

Balingen, 72336, Germany

Location

Site Reference ID/Investigator# 28021

Berlin, 10785, Germany

Location

Site Reference ID/Investigator# 28024

Berlin, 12435, Germany

Location

Site Reference ID/Investigator# 28303

Berlin, 12627, Germany

Location

Site Reference ID/Investigator# 54050

Berlin, 14193, Germany

Location

Site Reference ID/Investigator# 28022

Bernburg, 06406, Germany

Location

Site Reference ID/Investigator# 30862

Betzdorf, 57518, Germany

Location

Site Reference ID/Investigator# 28007

Bielefeld, 33609, Germany

Location

Site Reference ID/Investigator# 28304

Burg, 39288, Germany

Location

Site Reference ID/Investigator# 28014

Coburg, 96450, Germany

Location

Site Reference ID/Investigator# 28023

Cottbus, 03046, Germany

Location

Site Reference ID/Investigator# 28134

Demmin, 17109, Germany

Location

Site Reference ID/Investigator# 28037

Dresden, 01217, Germany

Location

Site Reference ID/Investigator# 43903

Dresden, 01307, Germany

Location

Site Reference ID/Investigator# 99777

Elmshorn, 25337, Germany

Location

Site Reference ID/Investigator# 28284

Elsenfeld, 63820, Germany

Location

Site Reference ID/Investigator# 124118

Emden, 26721, Germany

Location

Site Reference ID/Investigator# 54054

Emsdetten, 48282, Germany

Location

Site Reference ID/Investigator# 48864

Erfurt, 99089, Germany

Location

Site Reference ID/Investigator# 72343

Erkelenz, 41812, Germany

Location

Site Reference ID/Investigator# 28029

Eschweiler, 52249, Germany

Location

Site Reference ID/Investigator# 28287

Friedrichroda, 99894, Germany

Location

Site Reference ID/Investigator# 28276

Gera, 07548, Germany

Location

Site Reference ID/Investigator# 28351

Halle, 06118, Germany

Location

Site Reference ID/Investigator# 28280

Hamburg, 22767, Germany

Location

Site Reference ID/Investigator# 48865

Hanover, 30625, Germany

Location

Site Reference ID/Investigator# 28300

Heilbronn, 74076, Germany

Location

Site Reference ID/Investigator# 28011

Herford, 32049, Germany

Location

Site Reference ID/Investigator# 124119

Herne, 44623, Germany

Location

Site Reference ID/Investigator# 28019

Herzberg, 04916, Germany

Location

Site Reference ID/Investigator# 28135

Hildesheim, 31134, Germany

Location

Site Reference ID/Investigator# 28286

Hoyerswerda, 02977, Germany

Location

Site Reference ID/Investigator# 28353

Ilfeld, 99768, Germany

Location

Site Reference ID/Investigator# 28044

Jena, 07743, Germany

Location

Site Reference ID/Investigator# 48863

Kiel, 24106, Germany

Location

Site Reference ID/Investigator# 28013

Lahr, 77933, Germany

Location

Site Reference ID/Investigator# 28025

Loerrach, 79539, Germany

Location

Site Reference ID/Investigator# 28290

Ludwigslust, 19288, Germany

Location

Site Reference ID/Investigator# 10982

Magdeburg, 39108, Germany

Location

Site Reference ID/Investigator# 28291

Malente, 23714, Germany

Location

Site Reference ID/Investigator# 28036

Mannheim, 68309, Germany

Location

Site Reference ID/Investigator# 28302

Marburg, 35043, Germany

Location

Site Reference ID/Investigator# 54051

Minden, 32429, Germany

Location

Site Reference ID/Investigator# 99778

Munich, 80336, Germany

Location

Site Reference ID/Investigator# 28278

Müllheim, 79379, Germany

Location

Site Reference ID/Investigator# 99776

Neumünster, 24534, Germany

Location

Site Reference ID/Investigator# 124120

Nordhorn, 48527, Germany

Location

Site Reference ID/Investigator# 28275

Nordhorn, 48529, Germany

Location

Site Reference ID/Investigator# 43904

Oberstdorf, 87561, Germany

Location

Site Reference ID/Investigator# 28277

Osnabrück, 49074, Germany

Location

Site Reference ID/Investigator# 28297

Peine, 31224, Germany

Location

Site Reference ID/Investigator# 28307

Pirmasens, 66953, Germany

Location

Site Reference ID/Investigator# 28295

Potsdam, 14482, Germany

Location

Site Reference ID/Investigator# 28294

Quedlinburg, 06484, Germany

Location

Site Reference ID/Investigator# 48862

Rendsburg, 24768, Germany

Location

Site Reference ID/Investigator# 28042

Ribnitz-Damgarten, 18311, Germany

Location

Site Reference ID/Investigator# 28282

Rostock, 18107, Germany

Location

Site Reference ID/Investigator# 28033

Saint Wendel, 66606, Germany

Location

Site Reference ID/Investigator# 54052

Stuttgart, 70199, Germany

Location

Site Reference ID/Investigator# 28005

Stuttgart, 70376, Germany

Location

Site Reference ID/Investigator# 28020

Viersen, 41751, Germany

Location

Site Reference ID/Investigator# 28293

Villingen-Schwenningen, 78054, Germany

Location

Site Reference ID/Investigator# 28018

Völklingen, 66333, Germany

Location

Site Reference ID/Investigator# 28298

Weißenfels, 06667, Germany

Location

Site Reference ID/Investigator# 28292

Wetzlar, 35578, Germany

Location

Site Reference ID/Investigator# 48882

Wiesbaden, 65191, Germany

Location

Site Reference ID/Investigator# 28299

Wolfenbüttel, 38304, Germany

Location

Site Reference ID/Investigator# 28279

Zwickau, 08056, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency; Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Sabine Decker-Burgard, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 10, 2010
• Study Start: March 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

AU (11); DE (76)