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Chronic Kidney DiseasePhase 4IMPACT SHPTNCT00977080

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

A Phase 4 study testing Paricalcitol and Cinacalcet in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by Abbott at 83 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paricalcitol and Cinacalcet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
83 sitesin 12 countries
Study dates
Nov 2009to May 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

83 sites in 12 countries.

83 sites in 12 countries

United States30 sites

  • Site Reference ID/Investigator# 22772

    Aiken, South Carolina, 29801

  • Site Reference ID/Investigator# 23688

    Arvada, Colorado, 80002

  • Site Reference ID/Investigator# 22776

    Bluefield, West Virginia, 24701

  • Site Reference ID/Investigator# 24342

    Chula Vista, California, 91910

  • Site Reference ID/Investigator# 21370

    Coral Springs, Florida, 33071

  • Site Reference ID/Investigator# 21369

    Detroit, Michigan, 48202

  • Site Reference ID/Investigator# 22786

    Detroit, Michigan, 48236

  • Site Reference ID/Investigator# 22505

    Flushing, New York, 11355

  • Site Reference ID/Investigator# 22982

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 21143

    Houston, Texas, 77099

  • Site Reference ID/Investigator# 25902

    Hudson, Florida, 34667

  • Site Reference ID/Investigator# 22796

    Lancaster, Pennsylvania, 17604

  • Site Reference ID/Investigator# 21146

    Lauderdale Lakes, Florida, 33313

  • Site Reference ID/Investigator# 26743

    Lauderdale Lakes, Florida, 33313

  • Site Reference ID/Investigator# 21142

    Los Angeles, California, 90033

  • Site Reference ID/Investigator# 22762

    Los Angeles, California, 90048

  • Site Reference ID/Investigator# 22778

    Meridian, Idaho, 83642

  • Site Reference ID/Investigator# 22788

    Miami, Florida, 33173

  • Site Reference ID/Investigator# 21145

    Omaha, Nebraska, 68131

  • Site Reference ID/Investigator# 21147

    Orangeburg, South Carolina, 29115

  • Site Reference ID/Investigator# 22722

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 22770

    Philadelphia, Pennsylvania, 19106

  • Site Reference ID/Investigator# 22758

    Riverside, California, 92505

  • Site Reference ID/Investigator# 22506

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 21442

    San Diego, California, 92123

  • Site Reference ID/Investigator# 21144

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 21443

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 23147

    Tampa, Florida, 33614

  • Site Reference ID/Investigator# 22781

    Tempe, Arizona, 85284

  • Site Reference ID/Investigator# 22759

    Toledo, Ohio, 43606

Other trials in United States

Spain9 sites

  • Site Reference ID/Investigator# 21361

    Barcelona, 08025

  • Site Reference ID/Investigator# 21364

    Córdoba, 14004

  • Site Reference ID/Investigator# 22366

    L'Hospitalet, Barcelona, 08097

  • Site Reference ID/Investigator# 38343

    Madrid, 28040

  • Site Reference ID/Investigator# 21362

    Madrid, 28041

  • Site Reference ID/Investigator# 21363

    Palma de Mallorca, 07014

  • Site Reference ID/Investigator# 22367

    Pamplona, 31008

  • Site Reference ID/Investigator# 38462

    Puerto de la Cruz, 38400

  • Site Reference ID/Investigator# 21365

    Seville, 41007

Other trials in Spain

United Kingdom7 sites

  • Site Reference ID/Investigator# 23912

    Birmingham, B18 7QH

  • Site Reference ID/Investigator# 21747

    Coventry, CV2 2DX

  • Site Reference ID/Investigator# 23102

    London, NW3 2PF

  • Site Reference ID/Investigator# 23104

    London, SE1 9RT

  • Site Reference ID/Investigator# 23103

    Manchester, M6 8HD

  • Site Reference ID/Investigator# 41982

    Omagh, Northern Ireland, BT79 0AP

  • Site Reference ID/Investigator# 40222

    Sheffield, S5 7AU

Other trials in United Kingdom

Germany6 sites

  • Site Reference ID/Investigator# 21748

    Coburg, 96450

  • Site Reference ID/Investigator# 33268

    Darmstadt, 64295

  • Site Reference ID/Investigator# 35903

    Düsseldorf, 40210

  • Site Reference ID/Investigator# 21742

    Frankfurt, 60590

  • Site Reference ID/Investigator# 21744

    Heilbronn, 74076

  • Site Reference ID/Investigator# 21368

    Lüdenscheid, 58515

Other trials in Germany

Greece6 sites

  • Site Reference ID/Investigator# 22362

    Athens, 11528

  • Site Reference ID/Investigator# 38970

    Thessaloniki, 546 36

  • Site Reference ID/Investigator# 22322

    Thessaloniki, 54636

  • Site Reference ID/Investigator# 22463

    Thessaloniki, 54642

  • Site Reference ID/Investigator# 22323

    Thessaloniki, 56403

  • Site Reference ID/Investigator# 39262

    Thessaloniki, 570 01

Other trials in Greece

Italy6 sites

  • Site Reference ID/Investigator# 22312

    Bergamo, 24128

  • Site Reference ID/Investigator# 21746

    Genova, 16132

  • Site Reference ID/Investigator# 39180

    Lucca, 55100

  • Site Reference ID/Investigator# 22314

    Milan, 20122

  • Site Reference ID/Investigator# 21367

    Pavia, 27100

  • Site Reference ID/Investigator# 21745

    Pesaro, 61100

Other trials in Italy

Denmark4 sites

  • Site Reference ID/Investigator# 22363

    Aalborg, 9000

  • Site Reference ID/Investigator# 23105

    Copenhagen, 2100

  • Site Reference ID/Investigator# 23909

    Fredericia, 7000

  • Site Reference ID/Investigator# 22462

    Holstebro, 7500

Other trials in Denmark

Portugal4 sites

  • Site Reference ID/Investigator# 38903

    Beja, 7800-309

  • Site Reference ID/Investigator# 38531

    Faro, 8005- 546

  • Site Reference ID/Investigator# 22464

    Lisbon, 1750-130

  • Site Reference ID/Investigator# 23910

    Vila Franca de Xira, 2600-076

Other trials in Portugal

Czechia3 sites

  • Site Reference ID/Investigator# 22311

    Brno, 65691

  • Site Reference ID/Investigator# 22310

    Jilemnice, 51415

  • Site Reference ID/Investigator# 21624

    Ústí nad Labem, 40113

Other trials in Czechia

Netherlands3 sites

  • Site Reference ID/Investigator# 21842

    Alkmaar, 1815 JD

  • Site Reference ID/Investigator# 22309

    Delft, 2625 AD

  • Site Reference ID/Investigator# 21843

    Dordrecht, 3317 NM

Other trials in Netherlands

Sweden3 sites

  • Site Reference ID/Investigator# 23913

    Linköping, 58185

  • Site Reference ID/Investigator# 23782

    Stockholm, 182 88

  • Site Reference ID/Investigator# 22364

    Uppsala, 751 85

Other trials in Sweden

Russia2 sites

  • Site Reference ID/Investigator# 24643

    Moscow, 123182

  • Site Reference ID/Investigator# 24642

    Moscow, 125284

Other trials in Russia

About this study

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

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

Read the 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.

Being tested
Paricalcitol, Cinacalcet
Keywords
Zemplar, paricalcitol, IMPACT SHPT, Hemodialysis, Chronic Kidney Disease Stage 5
Medical subject headings
Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParicalcitolDrug

    Also called ABT-358, Zemplar

    Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia)

  • CinacalcetDrug

    Also called Sensipar, Mimpara, Hectorol

    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)

Study groups in NCT00977080
Study groupRoleWhat they receive
IV ParicalcitolActive comparatorParticipants 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.
Receives: Drug: Paricalcitol
Cinacalcet (at sites with IV paricalcitol)Active comparatorParticipants 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).
Receives: Drug: Cinacalcet
Oral paricalcitolActive comparatorParticipants 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.
Receives: Drug: Paricalcitol
Cinacalcet (at sites with oral paricalcitol)Active comparatorParticipants 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).
Receives: Drug: Cinacalcet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Weeks 21 to 28

Secondary outcomes (5)

  1. 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.

    Measured: Weeks 21 to 28

  2. 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.

    Measured: Weeks 21 to 28

  3. 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.

    Measured: Weeks 21 to 28

  4. 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.

    Measured: Weeks 21 to 28

  5. 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.

    Measured: Weeks 21 to 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00977080
Sponsor's protocol ID
M10-967
Other IDs
2009-011378-14, 2009
Acronym
IMPACT SHPT
Status last verified
May 2012
First submitted
14 Sep 2009
Last updated
20 Jun 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 24500308

  • 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.

    PubMed 24214232

  • 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.

    PubMed 22387567

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paricalcitol and Cinacalcet in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by Abbott at 83 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Spain, United Kingdom, Germany, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00977080, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.

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