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

NCT01401478 | Completed Results

• 1 other identifier: P12-838
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 13

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.

Conditions

Secondary Hyperparathyroidism

Keywords

Secondary Hyperparathyroidism; Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study

  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

  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

  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

  6 months

• Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study

  6 months

Study Arms (1)

Stage 5 Chronic Kidney Disease

Planned for Zemplar administration due to secondary hyperparathyroidism

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis centers

You may qualify if:

• Age 18-65 years
• Chronic Kidney Disease stage 5 receiving hemodialysis
• Authorization (Consent) for Use/Disclosure of Data signed by the patient
• 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
• Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL

You may not qualify if:

• 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
• Screening Ca x P \> 65 mg˄2/dL˄2
• Screening normalized serum total calcium \> 10.2 mg/dL
• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Almedis: collaborator

Study Sites (13)

Site Reference ID/Investigator# 57348

Al'met'yevsk, 423450, Russia

Location

Site Reference ID/Investigator# 57347

Cheboksary, 428018, Russia

Location

Site Reference ID/Investigator# 58347

Chelyabinsk, 454076, Russia

Location

Site Reference ID/Investigator# 67404

Iakutsk, 677019, Russia

Location

Site Reference ID/Investigator# 57344

Irkutsk, 664079 RF, Russia

Location

Site Reference ID/Investigator# 57346

Kazan', 420045, Russia

Location

Site Reference ID/Investigator# 58356

Moscow, 125284, Russia

Location

Site Reference ID/Investigator# 58348

Moscow, 127015, Russia

Location

Site Reference ID/Investigator# 57342

Novosibirsk, 630120, Russia

Location

Site Reference ID/Investigator# 57364

Orenburg, 460040, Russia

Location

Site Reference ID/Investigator# 57363

Saint Petersburg, 191104, Russia

Location

Site Reference ID/Investigator# 69687

Samara, 443095, Russia

Location

Site Reference ID/Investigator# 69688

Ulan-Ude, 670031, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

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

Results Point of Contact

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

800-633-9110

Study Officials

• Andrey Strugovshchikov, MD

  AbbVie LLC

  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: July 22, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 3, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-02

Locations

RU (13)