Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis

NCT00667576 | Completed Phase 2 Results

• 1 other identifier: M10-309
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.

Conditions

Chronic Kidney Disease on Hemodialysis; Secondary Hyperparathyroidism

Keywords

chronic kidney disease; secondary hyperparathyroidism; hemodialysis; paricalcitol; maxacalcitol

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level

  Baseline to Week 13 (Final Visit)

Secondary Outcomes (5)

• Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level

  Baseline to Week 13 (Final Visit)

• Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)

  Baseline to Week 13 (Final Visit)

• Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level

  Through Week 13

• Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values

  Through Week 13

• Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL

  Through Week 13

Other Outcomes (2)

• Percentage of Subjects With Hypercalcemia

  Through Week 13

• Percentage of Subjects With Hyperphosphatemia

  Through Week 13

Study Arms (5)

Paricalcitol 2 µg ± 1 µg

EXPERIMENTAL

Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg

Drug: Paricalcitol

Paricalcitol 2 µg ± 2 µg

EXPERIMENTAL

Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg

Drug: Paricalcitol

Paricalcitol 4 µg ± 1 µg

EXPERIMENTAL

Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg

Drug: Paricalcitol

Paricalcitol 4 µg ± 2 µg

EXPERIMENTAL

Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg

Drug: Paricalcitol

Maxacalcitol 5 or 10 µg ± 2.5 µg

OTHER

Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg

Drug: Maxacalcitol

Interventions

Maxacalcitol DRUG

Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.

Maxacalcitol 5 or 10 µg ± 2.5 µg

Paricalcitol DRUG

Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.

Also known as: ABT-358, Zemplar

Paricalcitol 2 µg ± 1 µg; Paricalcitol 2 µg ± 2 µg; Paricalcitol 4 µg ± 1 µg; Paricalcitol 4 µg ± 2 µg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
• Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
• Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
• Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
• Phosphorus ≤ 6.5 mg/dL
• Age ≥ 20 years

You may not qualify if:

• History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
• Parathyroidectomy or ethanol infusion within past year
• Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
• Drug or alcohol abuse within past 6 months
• Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
• Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
• Taking aluminum containing products (2 weeks prior to consent)

Sponsors & Collaborators

• Abbott: lead
• Abbott Japan Co.,Ltd: collaborator

Study Sites (12)

Unknown Facility

Tokyo, Metropolis, Japan

Location

Unknown Facility

Aichi, Prefecture, Japan

Location

Unknown Facility

Chiba, Prefecture, Japan

Location

Unknown Facility

Fukuoka, Prefecture, Japan

Location

Unknown Facility

Hokkaido, Prefecture, Japan

Location

Unknown Facility

Ibaraki, Prefecture, Japan

Location

Unknown Facility

Kanagawa, Prefecture, Japan

Location

Unknown Facility

Kumamoto, Prefecture, Japan

Location

Unknown Facility

Nagano, Prefecture, Japan

Location

Unknown Facility

Nagasaki, Prefecture, Japan

Location

Unknown Facility

Osaka, Prefecture, Japan

Location

Unknown Facility

Saitama, Prefecture, Japan

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

Interventions

maxacalcitol; paricalcitol

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

Limitations and Caveats

Different PTH thresholds were applied for suspending study drug: paricalcitol groups \<60 pg/mL, maxacalcitol group ≤150 pg/mL. This study was not statistically powered to compare treatments.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott Japan Co., Ltd.

800-633-9110

Study Officials

• Ryotaro Matsuzawa

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 20, 2012
• Results First Posted: April 2, 2010

Record last verified: 2012-01

Locations

JP (12)