Clinical trial NCT01401478: Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hyperparathyroidism
Keywords: Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Almedis
First posted: 2011-07-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis centers

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
timeFrame: 6 months
measure: Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study
timeFrame: 6 months
measure: Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
timeFrame: 6 months
measure: Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
timeFrame: 6 months
Other outcomes:
Locations:
city: Almetyevsk
country: Russian Federation
facility: Site Reference ID/Investigator# 57348
city: Cheboksary
country: Russian Federation
facility: Site Reference ID/Investigator# 57347
city: Chelyabinsk
country: Russian Federation
facility: Site Reference ID/Investigator# 58347
city: Iakutsk
country: Russian Federation
facility: Site Reference ID/Investigator# 67404
city: Irkutsk
country: Russian Federation
facility: Site Reference ID/Investigator# 57344
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 57346
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 58356
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 58348
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 57342
city: Orenburg
country: Russian Federation
facility: Site Reference ID/Investigator# 57364
city: Samara
country: Russian Federation
facility: Site Reference ID/Investigator# 69687
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 57363
city: Ulan-Ude
country: Russian Federation
facility: Site Reference ID/Investigator# 69688
Study officials:
affiliation: AbbVie LLC
name: Andrey Strugovshchikov, MD
role: STUDY_DIRECTOR
References: