Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

NCT01265992 | Completed Results

• 1 other identifier: P12-270
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden. This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Keywords

Secondary hyperparathyroidism; Mineral and Bone Disorder (CKD-MBD); Chronic Kidney Disease

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Intact Parathyroid Hormone at 6 Months

  Baseline and 6 months

• Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months

  Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are: Stage 3 CKD (estimated Glomerular Filtration Rate\* \[eGFR\] 30 - 59 mL/min): 3.85 - 7.7 pmol/L; Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L; Stage 5 CKD (eGFR \< 15 mL/min): 16.5 - 33 pmol/L. \*Calculated using the Modification of Diet in Renal Disease formula.

  Baseline and 6 months

• Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months

  Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as: Stage 3 CKD: ≥ 1.49 mmol/L; Stage 4 CKD: ≥ 1.49 mmol/L; Stage 5 CKD: \> 1.78 mmol/L.

  Baseline and 6 months

• Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months

  Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.

  Baseline and 6 months

Secondary Outcomes (6)

• Change From Baseline in Proteinuria

  Baseline and Month 6

• Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline

  Baseline and 6 months

• Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)

  Baseline and 6 months

• Total Direct Costs of Care Associated With Secondary Hyperparathyroidism

  6 months

• Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism

  6 months

Study Arms (1)

Paricalcitol capsules

Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.

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

Hospitals with nephrology clinic.

You may qualify if:

• Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se
• Patients must be 18 years or older with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10-59 by Modification of Diet in Renal Disease) but not yet on dialysis
• Patients should be in stable condition and have a life expectancy of at least 6 months
• Patients should not be expected to be transplanted or initiate dialysis for at least 6 months

You may not qualify if:

• Patients with CKD receiving dialysis
• Patients contraindicated for paricalcitol capsules as described in the SPC
• Treatment with paricalcitol more than 20 days prior to study enrollment
• History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Pharma Consulting Group AB: collaborator

Study Sites (10)

Site Reference ID/Investigator# 47723

Kalmar, 391 85, Sweden

Location

Site Reference ID/Investigator# 41084

Karlstad, 651 85, Sweden

Location

Site Reference ID/Investigator# 45190

Kristianstad, 291 85, Sweden

Location

Site Reference ID/Investigator# 41085

Linköping, 581 85, Sweden

Location

Site Reference ID/Investigator# 41087

Norrköping, 601 82, Sweden

Location

Site Reference ID/Investigator# 45188

Örebro, 701 85, Sweden

Location

Site Reference ID/Investigator# 41088

Skövde, 541 85, Sweden

Location

Site Reference ID/Investigator# 57782

Stockholm, 112 81, Sweden

Location

Site Reference ID/Investigator# 41089

Värnamo, 331 85, Sweden

Location

Site Reference ID/Investigator# 45191

Västerås, 721 89, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Calcinosis; Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Musculoskeletal Diseases; Rickets; Bone Diseases, Metabolic; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Results Point of Contact

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

800-633-9110

Study Officials

• Eva Dahl, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 24, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 19, 2014
• Results First Posted: February 19, 2014

Record last verified: 2014-01

Locations

SE (10)