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

This study has been completed.
Sponsor:
Collaborator:
Planimeter Ltd
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01273597
First received: November 22, 2010
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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.


Condition
Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).

  • Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy [ Time Frame: 6 months prior to start of study through baseline ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).


Enrollment: 60
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
End-stage kidney disease with secondary hyperparathyroidism
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary

Criteria

Inclusion Criteria:

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:

  1. ≥ 18 years of age,
  2. Willing to sign the patient information and informed consent form,
  3. 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.
  4. The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Exclusion Criteria:

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:

  1. The patient is already treated with Zemplar (paricalcitol injection),
  2. Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
  3. Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273597

Locations
Hungary
Site Reference ID/Investigator# 46585
Budapest, Hungary, 1115
Site Reference ID/Investigator# 46593
Budapest, Hungary, 1083
Site Reference ID/Investigator# 46594
Debrecen, Hungary, 4012
Site Reference ID/Investigator# 47722
Gyor, Hungary, 9023
Site Reference ID/Investigator# 46592
Karcag, Hungary, 5301
Site Reference ID/Investigator# 58644
Karcag, Hungary, 5301
Site Reference ID/Investigator# 46595
Miskolc, Hungary, 3501
Site Reference ID/Investigator# 46588
Nyiregyhaza, Hungary, 4400
Site Reference ID/Investigator# 46597
Pecs, Hungary, 7624
Site Reference ID/Investigator# 46590
Szombathely, Hungary, 9700
Site Reference ID/Investigator# 46591
Veszprem, Hungary, 8200
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Planimeter Ltd
Investigators
Study Director: Tamas Schnaider AbbVie (prior sponsor, Abbott)
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01273597     History of Changes
Other Study ID Numbers: P12-644
Study First Received: November 22, 2010
Results First Received: November 21, 2012
Last Updated: January 11, 2013
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee

Keywords provided by AbbVie:
Parathyroid hormone,Kidney failure, chronic,Hyperparathyroidism, secondary

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Renal Insufficiency
Endocrine System Diseases
Kidney Diseases
Parathyroid Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014