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Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis

Intervention: Paricalcitol (Drug); Cinacalcet (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Samina Khan, MD, Study Director, Affiliation: Abbott

Summary

Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.

Clinical Details

Official title: The IMPACT SHPT Study: Study to Evaluate the Improved Management of iPTH With Paricalcitol-centered Therapy vs. Cinacalcet Therapy With Low-dose Vitamin D in Hemodialysis Patients With Secondary Hyperparathyroidism

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28).

Secondary outcome:

Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).

Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).

Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata

Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)

Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)

Detailed description: During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i. e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as >= 10. 5 mg/dL). The evaluation period was from Weeks 21 to 28.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Male or female patients >= 18 years old. 2. Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during the 8 weeks prior to the screening period or naïve patients who had not received VDRA or cinacalcet within 8 weeks of screening. 3. Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3 months prior to screening and was expected to remain on HD for the duration of the study. 4. For entry into the Pre-Treatment Washout Period (for patients who were not naïve to VDRAs and cinacalcet), the patient had to have screening laboratory values of:

- iPTH level 130 to 700 pg/mL

- Serum Total Alkaline Phosphatase level >= 40 U/L

- Calcium level <= 10. 0 mg/dL (2. 49 mmol/L)

- Calcium-phosphorus product (CaxP) <= 75 mg2/dL2 (US) and <= 70 mg2/dL2 (non-US)

Exclusion Criteria 1. Patient had a history of parathyroidectomy. 2. Patient had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator. 3. Use of known inhibitors (i. e., ketoconazole) or inducers (i. e., carbamazepine) of cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6 (CYP2D6) (e. g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug administration. Commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by CYP2D6; thus, an adjustment to a lower dose may have been required. 4. Patient was known to be human immunodeficiency (HIV) positive.

Locations and Contacts

Site Reference ID/Investigator# 22311, Brno 65691, Czech Republic

Site Reference ID/Investigator# 22310, Jilemnice 51415, Czech Republic

Site Reference ID/Investigator# 21624, Usti nad Labem 40113, Czech Republic

Site Reference ID/Investigator# 22363, Aalborg 9000, Denmark

Site Reference ID/Investigator# 23105, Copenhagen 2100, Denmark

Site Reference ID/Investigator# 23909, Fredericia 7000, Denmark

Site Reference ID/Investigator# 22462, Holstebro 7500, Denmark

Site Reference ID/Investigator# 21748, Coburg 96450, Germany

Site Reference ID/Investigator# 33268, Darmstadt 64295, Germany

Site Reference ID/Investigator# 35903, Duesseldorf 40210, Germany

Site Reference ID/Investigator# 21742, Frankfurt 60590, Germany

Site Reference ID/Investigator# 21744, Heilbronn 74076, Germany

Site Reference ID/Investigator# 21368, Luedenscheid 58515, Germany

Site Reference ID/Investigator# 22362, Athens 11528, Greece

Site Reference ID/Investigator# 22322, Thessaloniki 54636, Greece

Site Reference ID/Investigator# 22323, Thessaloniki 56403, Greece

Site Reference ID/Investigator# 22463, Thessaloniki 54642, Greece

Site Reference ID/Investigator# 38970, Thessaloniki 546 36, Greece

Site Reference ID/Investigator# 39262, Thessaloniki 570 01, Greece

Site Reference ID/Investigator# 22312, Bergamo 24128, Italy

Site Reference ID/Investigator# 21746, Genova 16132, Italy

Site Reference ID/Investigator# 39180, Lucca 55100, Italy

Site Reference ID/Investigator# 22314, Milan 20122, Italy

Site Reference ID/Investigator# 21367, Pavia 27100, Italy

Site Reference ID/Investigator# 21745, Pesaro 61100, Italy

Site Reference ID/Investigator# 21842, Alkmaar 1815 JD, Netherlands

Site Reference ID/Investigator# 22309, Delft 2625 AD, Netherlands

Site Reference ID/Investigator# 21843, Dordrecht 3317 NM, Netherlands

Site Reference ID/Investigator# 38903, Beja 7800-309, Portugal

Site Reference ID/Investigator# 38531, Faro 8005- 546, Portugal

Site Reference ID/Investigator# 22464, Lisbon 1750-130, Portugal

Site Reference ID/Investigator# 23910, Vila Franca de Xira 2600-076, Portugal

Site Reference ID/Investigator# 24642, Moscow 125284, Russian Federation

Site Reference ID/Investigator# 24643, Moscow 123182, Russian Federation

Site Reference ID/Investigator# 21361, Barcelona 08025, Spain

Site Reference ID/Investigator# 21364, Cordoba 14004, Spain

Site Reference ID/Investigator# 22366, L'Hospitalet, Barcelona 08097, Spain

Site Reference ID/Investigator# 21362, Madrid 28041, Spain

Site Reference ID/Investigator# 38343, Madrid 28040, Spain

Site Reference ID/Investigator# 21363, Palma de Mallorca 07014, Spain

Site Reference ID/Investigator# 22367, Pamplona 31008, Spain

Site Reference ID/Investigator# 38462, Puerto de la Cruz 38400, Spain

Site Reference ID/Investigator# 21365, Seville 41007, Spain

Site Reference ID/Investigator# 23913, Linkoping 58185, Sweden

Site Reference ID/Investigator# 23782, Stockholm 182 88, Sweden

Site Reference ID/Investigator# 22364, Uppsala 751 85, Sweden

Site Reference ID/Investigator# 23912, Birmingham B18 7QH, United Kingdom

Site Reference ID/Investigator# 21747, Coventry CV2 2DX, United Kingdom

Site Reference ID/Investigator# 23102, London NW3 2PF, United Kingdom

Site Reference ID/Investigator# 23104, London SE1 9RT, United Kingdom

Site Reference ID/Investigator# 23103, Manchester M6 8HD, United Kingdom

Site Reference ID/Investigator# 41982, Omagh, Northern Ireland BT79 0AP, United Kingdom

Site Reference ID/Investigator# 40222, Sheffield S5 7AU, United Kingdom

Site Reference ID/Investigator# 22781, Tempe, Arizona 85284, United States

Site Reference ID/Investigator# 24342, Chula Vista, California 91910, United States

Site Reference ID/Investigator# 21142, Los Angeles, California 90033, United States

Site Reference ID/Investigator# 22762, Los Angeles, California 90048, United States

Site Reference ID/Investigator# 22758, Riverside, California 92505, United States

Site Reference ID/Investigator# 21442, San Diego, California 92123, United States

Site Reference ID/Investigator# 23688, Arvada, Colorado 80002, United States

Site Reference ID/Investigator# 21370, Coral Springs, Florida 33071, United States

Site Reference ID/Investigator# 25902, Hudson, Florida 34667, United States

Site Reference ID/Investigator# 21146, Lauderdale Lakes, Florida 33313, United States

Site Reference ID/Investigator# 26743, Lauderdale Lakes, Florida 33313, United States

Site Reference ID/Investigator# 22788, Miami, Florida 33173, United States

Site Reference ID/Investigator# 22722, Orlando, Florida 32806, United States

Site Reference ID/Investigator# 23147, Tampa, Florida 33614, United States

Site Reference ID/Investigator# 22778, Meridian, Idaho 83642, United States

Site Reference ID/Investigator# 21369, Detroit, Michigan 48202, United States

Site Reference ID/Investigator# 22786, Detroit, Michigan 48236, United States

Site Reference ID/Investigator# 21144, St. Louis, Missouri 63110, United States

Site Reference ID/Investigator# 21443, St. Louis, Missouri 63110, United States

Site Reference ID/Investigator# 21145, Omaha, Nebraska 68131, United States

Site Reference ID/Investigator# 22505, Flushing, New York 11355, United States

Site Reference ID/Investigator# 22759, Toledo, Ohio 43606, United States

Site Reference ID/Investigator# 22796, Lancaster, Pennsylvania 17604, United States

Site Reference ID/Investigator# 22770, Philadelphia, Pennsylvania 19106, United States

Site Reference ID/Investigator# 22772, Aiken, South Carolina 29801, United States

Site Reference ID/Investigator# 21147, Orangeburg, South Carolina 29115, United States

Site Reference ID/Investigator# 21143, Houston, Texas 77099, United States

Site Reference ID/Investigator# 22982, Houston, Texas 77030, United States

Site Reference ID/Investigator# 22506, San Antonio, Texas 78215, United States

Site Reference ID/Investigator# 22776, Bluefield, West Virginia 24701, United States

Additional Information

Starting date: November 2009
Last updated: May 18, 2012

Page last updated: August 23, 2015

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