Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

Prospective, Open-label, Multicenter Effectiveness and Safety Observational Study of Zemplar in Patients With Stage 5 Chronic Kidney Disease and Hyperparathyroidism on Hemodialysis in the Russian Federation

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism

Detailed Description

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.

Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).

Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.

The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Russian Federation
  • Almetyevsk, Russian Federation, 423450
    • Site Reference ID/Investigator# 57348
  • Cheboksary, Russian Federation, 428018
    • Site Reference ID/Investigator# 57347
  • Chelyabinsk, Russian Federation, 454076
    • Site Reference ID/Investigator# 58347
  • Iakutsk, Russian Federation, 677019
    • Site Reference ID/Investigator# 67404
  • Irkutsk, Russian Federation, 664079 RF
    • Site Reference ID/Investigator# 57344
  • Kazan, Russian Federation, 420045
    • Site Reference ID/Investigator# 57346
  • Moscow, Russian Federation, 125284
    • Site Reference ID/Investigator# 58356
  • Moscow, Russian Federation, 127015
    • Site Reference ID/Investigator# 58348
  • Novosibirsk, Russian Federation, 630120
    • Site Reference ID/Investigator# 57342
  • Orenburg, Russian Federation, 460040
    • Site Reference ID/Investigator# 57364
  • Samara, Russian Federation, 443095
    • Site Reference ID/Investigator# 69687
  • St. Petersburg, Russian Federation, 191104
    • Site Reference ID/Investigator# 57363
  • Ulan-Ude, Russian Federation, 670031
    • Site Reference ID/Investigator# 69688

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis centers

Description

Inclusion Criteria:

1. Age 18-65 years
2. Chronic Kidney Disease stage 5 receiving hemodialysis
3. Authorization (Consent) for Use/Disclosure of Data signed by the patient
4. Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program
5. Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL

Exclusion Criteria:

1. Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy
2. Any experimental drug within the period of 30 days before the inclusion into the program
3. Screening Ca x P > 65 mg˄2/dL˄2
4. Screening normalized serum total calcium > 10.2 mg/dL
5. Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stage 5 Chronic Kidney Disease; Planned for Zemplar administration due to secondary hyperparathyroidism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study	The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study	The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.	6 months
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study	The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.	6 months
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study	The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.	6 months
Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study	The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.	6 months
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study	The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.	6 months
Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study	The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.	6 months
Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination	The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.	6 months

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Almedis
• Investigators: Study Director: Andrey Strugovshchikov, MD, AbbVie LLC

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 22, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Renal Insufficiency; Secondary Hyperparathyroidism
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Parathyroid Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
• Other Study ID Numbers: P12-838