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

NCT01273597 | Completed Results

• 1 other identifier: P12-644
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Kidney Failure, Chronic

Keywords

Parathyroid hormone,Kidney failure, chronic,Hyperparathyroidism, secondary

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (8)

• Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6

  6 months

• Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance

  6 months prior to start of study through 6 months of treatment

• Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance

  6 months prior to start of study through 6 months of treatment

• Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism

  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

  6 months prior to start of study through baseline

Study Arms (1)

End-stage kidney disease with secondary hyperparathyroidism

Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

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

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Planimeter Ltd: collaborator

Study Sites (11)

Site Reference ID/Investigator# 46593

Budapest, 1083, Hungary

Location

Site Reference ID/Investigator# 46585

Budapest, 1115, Hungary

Location

Site Reference ID/Investigator# 46594

Debrecen, 4012, Hungary

Location

Site Reference ID/Investigator# 47722

Győr, 9023, Hungary

Location

Site Reference ID/Investigator# 46592

Karcag, 5301, Hungary

Location

Site Reference ID/Investigator# 58644

Karcag, 5301, Hungary

Location

Site Reference ID/Investigator# 46595

Miskolc, 3501, Hungary

Location

Site Reference ID/Investigator# 46588

Nyíregyháza, 4400, Hungary

Location

Site Reference ID/Investigator# 46597

Pécs, 7624, Hungary

Location

Site Reference ID/Investigator# 46590

Szombathely, 9700, Hungary

Location

Site Reference ID/Investigator# 46591

Veszprém, 8200, Hungary

Location

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Neoplastic Processes; Neoplasms

Results Point of Contact

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

800-633-9110

Study Officials

• Tamas Schnaider

  AbbVie (prior sponsor, Abbott)

  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: November 22, 2010
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: December 21, 2012

Record last verified: 2013-01

Locations

HU (11)