Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D (IMPACT SHPT)

May 18, 2012 updated by: Abbott

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 65691
        • Site Reference ID/Investigator# 22311
      • Jilemnice, Czech Republic, 51415
        • Site Reference ID/Investigator# 22310
      • Usti nad Labem, Czech Republic, 40113
        • Site Reference ID/Investigator# 21624
  • Denmark
      • Aalborg, Denmark, 9000
        • Site Reference ID/Investigator# 22363
      • Copenhagen, Denmark, 2100
        • Site Reference ID/Investigator# 23105
      • Fredericia, Denmark, 7000
        • Site Reference ID/Investigator# 23909
      • Holstebro, Denmark, 7500
        • Site Reference ID/Investigator# 22462
  • Germany
      • Coburg, Germany, 96450
        • Site Reference ID/Investigator# 21748
      • Darmstadt, Germany, 64295
        • Site Reference ID/Investigator# 33268
      • Duesseldorf, Germany, 40210
        • Site Reference ID/Investigator# 35903
      • Frankfurt, Germany, 60590
        • Site Reference ID/Investigator# 21742
      • Heilbronn, Germany, 74076
        • Site Reference ID/Investigator# 21744
      • Luedenscheid, Germany, 58515
        • Site Reference ID/Investigator# 21368
  • Greece
      • Athens, Greece, 11528
        • Site Reference ID/Investigator# 22362
      • Thessaloniki, Greece, 546 36
        • Site Reference ID/Investigator# 38970
      • Thessaloniki, Greece, 54636
        • Site Reference ID/Investigator# 22322
      • Thessaloniki, Greece, 54642
        • Site Reference ID/Investigator# 22463
      • Thessaloniki, Greece, 56403
        • Site Reference ID/Investigator# 22323
      • Thessaloniki, Greece, 570 01
        • Site Reference ID/Investigator# 39262
  • Italy
      • Bergamo, Italy, 24128
        • Site Reference ID/Investigator# 22312
      • Genova, Italy, 16132
        • Site Reference ID/Investigator# 21746
      • Lucca, Italy, 55100
        • Site Reference ID/Investigator# 39180
      • Milan, Italy, 20122
        • Site Reference ID/Investigator# 22314
      • Pavia, Italy, 27100
        • Site Reference ID/Investigator# 21367
      • Pesaro, Italy, 61100
        • Site Reference ID/Investigator# 21745
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Site Reference ID/Investigator# 21842
      • Delft, Netherlands, 2625 AD
        • Site Reference ID/Investigator# 22309
      • Dordrecht, Netherlands, 3317 NM
        • Site Reference ID/Investigator# 21843
  • Portugal
      • Beja, Portugal, 7800-309
        • Site Reference ID/Investigator# 38903
      • Faro, Portugal, 8005- 546
        • Site Reference ID/Investigator# 38531
      • Lisbon, Portugal, 1750-130
        • Site Reference ID/Investigator# 22464
      • Vila Franca de Xira, Portugal, 2600-076
        • Site Reference ID/Investigator# 23910
  • Russian Federation
      • Moscow, Russian Federation, 123182
        • Site Reference ID/Investigator# 24643
      • Moscow, Russian Federation, 125284
        • Site Reference ID/Investigator# 24642
  • Spain
      • Barcelona, Spain, 08025
        • Site Reference ID/Investigator# 21361
      • Cordoba, Spain, 14004
        • Site Reference ID/Investigator# 21364
      • L'Hospitalet, Barcelona, Spain, 08097
        • Site Reference ID/Investigator# 22366
      • Madrid, Spain, 28040
        • Site Reference ID/Investigator# 38343
      • Madrid, Spain, 28041
        • Site Reference ID/Investigator# 21362
      • Palma de Mallorca, Spain, 07014
        • Site Reference ID/Investigator# 21363
      • Pamplona, Spain, 31008
        • Site Reference ID/Investigator# 22367
      • Puerto de la Cruz, Spain, 38400
        • Site Reference ID/Investigator# 38462
      • Seville, Spain, 41007
        • Site Reference ID/Investigator# 21365
  • Sweden
      • Linkoping, Sweden, 58185
        • Site Reference ID/Investigator# 23913
      • Stockholm, Sweden, 182 88
        • Site Reference ID/Investigator# 23782
      • Uppsala, Sweden, 751 85
        • Site Reference ID/Investigator# 22364
  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Site Reference ID/Investigator# 23912
      • Coventry, United Kingdom, CV2 2DX
        • Site Reference ID/Investigator# 21747
      • London, United Kingdom, NW3 2PF
        • Site Reference ID/Investigator# 23102
      • London, United Kingdom, SE1 9RT
        • Site Reference ID/Investigator# 23104
      • Manchester, United Kingdom, M6 8HD
        • Site Reference ID/Investigator# 23103
      • Omagh, Northern Ireland, United Kingdom, BT79 0AP
        • Site Reference ID/Investigator# 41982
      • Sheffield, United Kingdom, S5 7AU
        • Site Reference ID/Investigator# 40222
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Site Reference ID/Investigator# 22781
    • California
      • Chula Vista, California, United States, 91910
        • Site Reference ID/Investigator# 24342
      • Los Angeles, California, United States, 90033
        • Site Reference ID/Investigator# 21142
      • Los Angeles, California, United States, 90048
        • Site Reference ID/Investigator# 22762
      • Riverside, California, United States, 92505
        • Site Reference ID/Investigator# 22758
      • San Diego, California, United States, 92123
        • Site Reference ID/Investigator# 21442
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Site Reference ID/Investigator# 23688
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Site Reference ID/Investigator# 21370
      • Hudson, Florida, United States, 34667
        • Site Reference ID/Investigator# 25902
      • Lauderdale Lakes, Florida, United States, 33313
        • Site Reference ID/Investigator# 21146
      • Lauderdale Lakes, Florida, United States, 33313
        • Site Reference ID/Investigator# 26743
      • Miami, Florida, United States, 33173
        • Site Reference ID/Investigator# 22788
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 22722
      • Tampa, Florida, United States, 33614
        • Site Reference ID/Investigator# 23147
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Site Reference ID/Investigator# 22778
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Site Reference ID/Investigator# 21369
      • Detroit, Michigan, United States, 48236
        • Site Reference ID/Investigator# 22786
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 21144
      • St. Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 21443
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 21145
    • New York
      • Flushing, New York, United States, 11355
        • Site Reference ID/Investigator# 22505
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Site Reference ID/Investigator# 22759
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Site Reference ID/Investigator# 22796
      • Philadelphia, Pennsylvania, United States, 19106
        • Site Reference ID/Investigator# 22770
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Site Reference ID/Investigator# 22772
      • Orangeburg, South Carolina, United States, 29115
        • Site Reference ID/Investigator# 21147
    • Texas
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 22982
      • Houston, Texas, United States, 77099
        • Site Reference ID/Investigator# 21143
      • San Antonio, Texas, United States, 78215
        • Site Reference ID/Investigator# 22506
    • West Virginia
      • Bluefield, West Virginia, United States, 24701
        • Site Reference ID/Investigator# 22776

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IV Paricalcitol
Participants in the IV stratum received intravenous (IV) paricalcitol and, if hypercalcemia (calcium >= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at 0.07 mcg/kg with titration every 2 weeks.
Drug: Paricalcitol
Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)
Other Names:
  • Zemplar
  • ABT-358
ACTIVE_COMPARATOR: Cinacalcet (at sites with IV paricalcitol)
Participants in the IV stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (doxercalciferol IV 1 mcg 3 times weekly (TIW) at sites in the US and alfacalcidol capsules 0.25 mcg daily at sites in Russia).
Drug: Cinacalcet
On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)
Other Names:
  • Mimpara
  • Sensipar
  • Hectorol
ACTIVE_COMPARATOR: Oral paricalcitol
Participants in the oral stratum received oral paricalcitol and, if hypercalcemia (calcium >= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at mcg = IPTH/60 3 times weekly (TIW) with titration every 2 weeks.
Drug: Paricalcitol
Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)
Other Names:
  • Zemplar
  • ABT-358
ACTIVE_COMPARATOR: Cinacalcet (at sites with oral paricalcitol)
Participants in the oral stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (alfacalcidol capsules 0.25 mcg daily).
Drug: Cinacalcet
On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)
Other Names:
  • Mimpara
  • Sensipar
  • Hectorol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Weeks 21 to 28
iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.
Weeks 21 to 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Weeks 21 to 28
iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.
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).
Time Frame: Weeks 21 to 28
iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted.
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
Time Frame: Weeks 21 to 28
iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together.
Weeks 21 to 28
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)
Time Frame: Weeks 21 to 28
Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted.
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)
Time Frame: Weeks 21 to 28
Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted.
Weeks 21 to 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Samina Khan, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (ESTIMATE)

September 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-967
  • 2009-011378-14 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis

Clinical Trials on Paricalcitol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe