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

Primary Purpose

Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Paricalcitol
Cinacalcet
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Zemplar, paricalcitol, IMPACT SHPT, Hemodialysis, Chronic Kidney Disease Stage 5

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 22781
  • Site Reference ID/Investigator# 24342
  • Site Reference ID/Investigator# 21142
  • Site Reference ID/Investigator# 22762
  • Site Reference ID/Investigator# 22758
  • Site Reference ID/Investigator# 21442
  • Site Reference ID/Investigator# 23688
  • Site Reference ID/Investigator# 21370
  • Site Reference ID/Investigator# 25902
  • Site Reference ID/Investigator# 21146
  • Site Reference ID/Investigator# 26743
  • Site Reference ID/Investigator# 22788
  • Site Reference ID/Investigator# 22722
  • Site Reference ID/Investigator# 23147
  • Site Reference ID/Investigator# 22778
  • Site Reference ID/Investigator# 21369
  • Site Reference ID/Investigator# 22786
  • Site Reference ID/Investigator# 21144
  • Site Reference ID/Investigator# 21443
  • Site Reference ID/Investigator# 21145
  • Site Reference ID/Investigator# 22505
  • Site Reference ID/Investigator# 22759
  • Site Reference ID/Investigator# 22796
  • Site Reference ID/Investigator# 22770
  • Site Reference ID/Investigator# 22772
  • Site Reference ID/Investigator# 21147
  • Site Reference ID/Investigator# 22982
  • Site Reference ID/Investigator# 21143
  • Site Reference ID/Investigator# 22506
  • Site Reference ID/Investigator# 22776
  • Site Reference ID/Investigator# 22311
  • Site Reference ID/Investigator# 22310
  • Site Reference ID/Investigator# 21624
  • Site Reference ID/Investigator# 22363
  • Site Reference ID/Investigator# 23105
  • Site Reference ID/Investigator# 23909
  • Site Reference ID/Investigator# 22462
  • Site Reference ID/Investigator# 21748
  • Site Reference ID/Investigator# 33268
  • Site Reference ID/Investigator# 35903
  • Site Reference ID/Investigator# 21742
  • Site Reference ID/Investigator# 21744
  • Site Reference ID/Investigator# 21368
  • Site Reference ID/Investigator# 22362
  • Site Reference ID/Investigator# 38970
  • Site Reference ID/Investigator# 22322
  • Site Reference ID/Investigator# 22463
  • Site Reference ID/Investigator# 22323
  • Site Reference ID/Investigator# 39262
  • Site Reference ID/Investigator# 22312
  • Site Reference ID/Investigator# 21746
  • Site Reference ID/Investigator# 39180
  • Site Reference ID/Investigator# 22314
  • Site Reference ID/Investigator# 21367
  • Site Reference ID/Investigator# 21745
  • Site Reference ID/Investigator# 21842
  • Site Reference ID/Investigator# 22309
  • Site Reference ID/Investigator# 21843
  • Site Reference ID/Investigator# 38903
  • Site Reference ID/Investigator# 38531
  • Site Reference ID/Investigator# 22464
  • Site Reference ID/Investigator# 23910
  • Site Reference ID/Investigator# 24643
  • Site Reference ID/Investigator# 24642
  • Site Reference ID/Investigator# 21361
  • Site Reference ID/Investigator# 21364
  • Site Reference ID/Investigator# 22366
  • Site Reference ID/Investigator# 38343
  • Site Reference ID/Investigator# 21362
  • Site Reference ID/Investigator# 21363
  • Site Reference ID/Investigator# 22367
  • Site Reference ID/Investigator# 38462
  • Site Reference ID/Investigator# 21365
  • Site Reference ID/Investigator# 23913
  • Site Reference ID/Investigator# 23782
  • Site Reference ID/Investigator# 22364
  • Site Reference ID/Investigator# 23912
  • Site Reference ID/Investigator# 21747
  • Site Reference ID/Investigator# 23102
  • Site Reference ID/Investigator# 23104
  • Site Reference ID/Investigator# 23103
  • Site Reference ID/Investigator# 41982
  • Site Reference ID/Investigator# 40222

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IV Paricalcitol

Cinacalcet (at sites with IV paricalcitol)

Oral paricalcitol

Cinacalcet (at sites with oral paricalcitol)

Arm Description

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.

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).

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.

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).

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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.
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).
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.
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
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.
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)
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.
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)
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.

Full Information

First Posted
September 14, 2009
Last Updated
May 18, 2012
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00977080
Brief Title
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Acronym
IMPACT SHPT
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
Keywords
Zemplar, paricalcitol, IMPACT SHPT, Hemodialysis, Chronic Kidney Disease Stage 5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Paricalcitol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cinacalcet (at sites with IV paricalcitol)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Oral paricalcitol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cinacalcet (at sites with oral paricalcitol)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
ABT-358, Zemplar
Intervention Description
Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Sensipar, Mimpara, Hectorol
Intervention Description
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)
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Weeks 21 to 28
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Weeks 21 to 28
Title
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).
Description
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.
Time Frame
Weeks 21 to 28
Title
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
Description
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.
Time Frame
Weeks 21 to 28
Title
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)
Description
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.
Time Frame
Weeks 21 to 28
Title
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)
Description
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.
Time Frame
Weeks 21 to 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male or female patients >= 18 years old. 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. 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. 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 Patient had a history of parathyroidectomy. 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. 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. Patient was known to be human immunodeficiency (HIV) positive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samina Khan, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 22781
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Site Reference ID/Investigator# 24342
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Site Reference ID/Investigator# 21142
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Site Reference ID/Investigator# 22762
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site Reference ID/Investigator# 22758
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Site Reference ID/Investigator# 21442
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Reference ID/Investigator# 23688
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Site Reference ID/Investigator# 21370
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Site Reference ID/Investigator# 25902
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Site Reference ID/Investigator# 21146
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Site Reference ID/Investigator# 26743
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Site Reference ID/Investigator# 22788
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Site Reference ID/Investigator# 22722
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 23147
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Site Reference ID/Investigator# 22778
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Site Reference ID/Investigator# 21369
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Site Reference ID/Investigator# 22786
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Site Reference ID/Investigator# 21144
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator# 21443
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator# 21145
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Site Reference ID/Investigator# 22505
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Site Reference ID/Investigator# 22759
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Site Reference ID/Investigator# 22796
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Site Reference ID/Investigator# 22770
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Site Reference ID/Investigator# 22772
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
Site Reference ID/Investigator# 21147
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29115
Country
United States
Facility Name
Site Reference ID/Investigator# 22982
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 21143
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Site Reference ID/Investigator# 22506
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Site Reference ID/Investigator# 22776
City
Bluefield
State/Province
West Virginia
ZIP/Postal Code
24701
Country
United States
Facility Name
Site Reference ID/Investigator# 22311
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 22310
City
Jilemnice
ZIP/Postal Code
51415
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 21624
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 22363
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Site Reference ID/Investigator# 23105
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Site Reference ID/Investigator# 23909
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Name
Site Reference ID/Investigator# 22462
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Site Reference ID/Investigator# 21748
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Site Reference ID/Investigator# 33268
City
Darmstadt
ZIP/Postal Code
64295
Country
Germany
Facility Name
Site Reference ID/Investigator# 35903
City
Duesseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Site Reference ID/Investigator# 21742
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Site Reference ID/Investigator# 21744
City
Heilbronn
ZIP/Postal Code
74076
Country
Germany
Facility Name
Site Reference ID/Investigator# 21368
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Site Reference ID/Investigator# 22362
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Site Reference ID/Investigator# 38970
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Site Reference ID/Investigator# 22322
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Site Reference ID/Investigator# 22463
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Site Reference ID/Investigator# 22323
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Site Reference ID/Investigator# 39262
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
Site Reference ID/Investigator# 22312
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Site Reference ID/Investigator# 21746
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Site Reference ID/Investigator# 39180
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Site Reference ID/Investigator# 22314
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Site Reference ID/Investigator# 21367
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Site Reference ID/Investigator# 21745
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Site Reference ID/Investigator# 21842
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 22309
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 21843
City
Dordrecht
ZIP/Postal Code
3317 NM
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 38903
City
Beja
ZIP/Postal Code
7800-309
Country
Portugal
Facility Name
Site Reference ID/Investigator# 38531
City
Faro
ZIP/Postal Code
8005- 546
Country
Portugal
Facility Name
Site Reference ID/Investigator# 22464
City
Lisbon
ZIP/Postal Code
1750-130
Country
Portugal
Facility Name
Site Reference ID/Investigator# 23910
City
Vila Franca de Xira
ZIP/Postal Code
2600-076
Country
Portugal
Facility Name
Site Reference ID/Investigator# 24643
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 24642
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 21361
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Site Reference ID/Investigator# 21364
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Site Reference ID/Investigator# 22366
City
L'Hospitalet, Barcelona
ZIP/Postal Code
08097
Country
Spain
Facility Name
Site Reference ID/Investigator# 38343
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Site Reference ID/Investigator# 21362
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site Reference ID/Investigator# 21363
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Site Reference ID/Investigator# 22367
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Site Reference ID/Investigator# 38462
City
Puerto de la Cruz
ZIP/Postal Code
38400
Country
Spain
Facility Name
Site Reference ID/Investigator# 21365
City
Seville
ZIP/Postal Code
41007
Country
Spain
Facility Name
Site Reference ID/Investigator# 23913
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Site Reference ID/Investigator# 23782
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Site Reference ID/Investigator# 22364
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Site Reference ID/Investigator# 23912
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 21747
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 23102
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 23104
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 23103
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 41982
City
Omagh, Northern Ireland
ZIP/Postal Code
BT79 0AP
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 40222
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24500308
Citation
Cozzolino M, Ketteler M, Martin KJ, Sharma A, Goldsmith D, Khan S. Paricalcitol- or cinacalcet-centred therapy affects markers of bone mineral disease in patients with secondary hyperparathyroidism receiving haemodialysis: results of the IMPACT-SHPT study. Nephrol Dial Transplant. 2014 Apr;29(4):899-905. doi: 10.1093/ndt/gfu011. Epub 2014 Feb 4.
Results Reference
derived
PubMed Identifier
24214232
Citation
Sharma A, Marshall TS, Khan SS, Johns B. Cost effectiveness of paricalcitol versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients in the USA. Clin Drug Investig. 2014 Feb;34(2):107-15. doi: 10.1007/s40261-013-0151-4. Erratum In: Clin Drug Investig. 2014 Feb;34(2):163.
Results Reference
derived
PubMed Identifier
22387567
Citation
Ketteler M, Martin KJ, Wolf M, Amdahl M, Cozzolino M, Goldsmith D, Sharma A, Marx S, Khan S. Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant. 2012 Aug;27(8):3270-8. doi: 10.1093/ndt/gfs018. Epub 2012 Mar 2.
Results Reference
derived

Learn more about this trial

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

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