MedDataX Logo

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

NCT ID: NCT00977080

Last Updated: 2012-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

NCT01181531

Hyperparathyroidism, Secondary
COMPLETED PHASE4

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

NCT00823303

Secondary Hyperparathyroidism Chronic Kidney Disease
COMPLETED PHASE4

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

NCT01932970

Hyperparathyroidism, Secondary
COMPLETED PHASE3

20070360 Incident Dialysis

NCT00803712

Chronic Kidney Disease Secondary Hyperparathyroidism
COMPLETED PHASE4

Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

NCT00990704

Secondary Hyperparathyroidism Hemodialysis
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Secondary Hyperparathyroidism Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Paricalcitol

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Cinacalcet

Intervention Type DRUG

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)

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.

Group Type ACTIVE_COMPARATOR

Paricalcitol

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Cinacalcet

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paricalcitol

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

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-358 Zemplar Sensipar Mimpara Hectorol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Samina Khan, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 22781

Tempe, Arizona, United States

Site Status

Site Reference ID/Investigator# 24342

Chula Vista, California, United States

Site Status

Site Reference ID/Investigator# 21142

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 22762

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 22758

Riverside, California, United States

Site Status

Site Reference ID/Investigator# 21442

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 23688

Arvada, Colorado, United States

Site Status

Site Reference ID/Investigator# 21370

Coral Springs, Florida, United States

Site Status

Site Reference ID/Investigator# 25902

Hudson, Florida, United States

Site Status

Site Reference ID/Investigator# 21146

Lauderdale Lakes, Florida, United States

Site Status

Site Reference ID/Investigator# 26743

Lauderdale Lakes, Florida, United States

Site Status

Site Reference ID/Investigator# 22788

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 22722

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 23147

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 22778

Meridian, Idaho, United States

Site Status

Site Reference ID/Investigator# 21369

Detroit, Michigan, United States

Site Status

Site Reference ID/Investigator# 22786

Detroit, Michigan, United States

Site Status

Site Reference ID/Investigator# 21144

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 21443

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 21145

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 22505

Flushing, New York, United States

Site Status

Site Reference ID/Investigator# 22759

Toledo, Ohio, United States

Site Status

Site Reference ID/Investigator# 22796

Lancaster, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 22770

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 22772

Aiken, South Carolina, United States

Site Status

Site Reference ID/Investigator# 21147

Orangeburg, South Carolina, United States

Site Status

Site Reference ID/Investigator# 22982

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 21143

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 22506

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 22776

Bluefield, West Virginia, United States

Site Status

Site Reference ID/Investigator# 22311

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 22310

Jilemnice, , Czechia

Site Status

Site Reference ID/Investigator# 21624

Ústí nad Labem, , Czechia

Site Status

Site Reference ID/Investigator# 22363

Aalborg, , Denmark

Site Status

Site Reference ID/Investigator# 23105

Copenhagen, , Denmark

Site Status

Site Reference ID/Investigator# 23909

Fredericia, , Denmark

Site Status

Site Reference ID/Investigator# 22462

Holstebro, , Denmark

Site Status

Site Reference ID/Investigator# 21748

Coburg, , Germany

Site Status

Site Reference ID/Investigator# 33268

Darmstadt, , Germany

Site Status

Site Reference ID/Investigator# 35903

Düsseldorf, , Germany

Site Status

Site Reference ID/Investigator# 21742

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 21744

Heilbronn, , Germany

Site Status

Site Reference ID/Investigator# 21368

Lüdenscheid, , Germany

Site Status

Site Reference ID/Investigator# 22362

Athens, , Greece

Site Status

Site Reference ID/Investigator# 38970

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 22322

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 22463

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 22323

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 39262

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 22312

Bergamo, , Italy

Site Status

Site Reference ID/Investigator# 21746

Genova, , Italy

Site Status

Site Reference ID/Investigator# 39180

Lucca, , Italy

Site Status

Site Reference ID/Investigator# 22314

Milan, , Italy

Site Status

Site Reference ID/Investigator# 21367

Pavia, , Italy

Site Status

Site Reference ID/Investigator# 21745

Pesaro, , Italy

Site Status

Site Reference ID/Investigator# 21842

Alkmaar, , Netherlands

Site Status

Site Reference ID/Investigator# 22309

Delft, , Netherlands

Site Status

Site Reference ID/Investigator# 21843

Dordrecht, , Netherlands

Site Status

Site Reference ID/Investigator# 38903

Beja, , Portugal

Site Status

Site Reference ID/Investigator# 38531

Faro, , Portugal

Site Status

Site Reference ID/Investigator# 22464

Lisbon, , Portugal

Site Status

Site Reference ID/Investigator# 23910

Vila Franca de Xira, , Portugal

Site Status

Site Reference ID/Investigator# 24643

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 24642

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 21361

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 21364

Córdoba, , Spain

Site Status

Site Reference ID/Investigator# 22366

L'Hospitalet, Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 38343

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 21362

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 21363

Palma de Mallorca, , Spain

Site Status

Site Reference ID/Investigator# 22367

Pamplona, , Spain

Site Status

Site Reference ID/Investigator# 38462

Puerto de la Cruz, , Spain

Site Status

Site Reference ID/Investigator# 21365

Seville, , Spain

Site Status

Site Reference ID/Investigator# 23913

Linköping, , Sweden

Site Status

Site Reference ID/Investigator# 23782

Stockholm, , Sweden

Site Status

Site Reference ID/Investigator# 22364

Uppsala, , Sweden

Site Status

Site Reference ID/Investigator# 23912

Birmingham, , United Kingdom

Site Status

Site Reference ID/Investigator# 21747

Coventry, , United Kingdom

Site Status

Site Reference ID/Investigator# 23102

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 23104

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 23103

Manchester, , United Kingdom

Site Status

Site Reference ID/Investigator# 41982

Omagh, Northern Ireland, , United Kingdom

Site Status

Site Reference ID/Investigator# 40222

Sheffield, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Czechia Denmark Germany Greece Italy Netherlands Portugal Russia Spain Sweden United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24500308 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24214232 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22387567 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-011378-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-967

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
NCT01071070 COMPLETED PHASE3
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
NCT01101113 COMPLETED PHASE4
Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism
NCT00307840 COMPLETED PHASE4
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01785875 COMPLETED PHASE3
Treatment Adhesion in Dialysis Patients Treated With Cinacalcet
NCT01573520 COMPLETED PHASE4
Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
NCT00664430 TERMINATED PHASE4
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
NCT00117052 COMPLETED PHASE3
Intravenous Paricalcitol in Chronic Hemodialysis Patients
NCT03023748 UNKNOWN PHASE4
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
NCT03299244 COMPLETED PHASE3
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01788046 COMPLETED PHASE3
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
NCT04064827 TERMINATED PHASE3
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
NCT01896232 COMPLETED PHASE3
Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
NCT00094484 COMPLETED PHASE3
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
NCT03123406 COMPLETED PHASE4
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
NCT00667576 COMPLETED PHASE2
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)
NCT00048516 COMPLETED PHASE3
Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients
NCT02338934 UNKNOWN PHASE4
DePTH: De-emphasize PTH
NCT06288451 ACTIVE_NOT_RECRUITING PHASE2
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
NCT00261950 COMPLETED PHASE2
Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
NCT00048438 COMPLETED PHASE3
Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
NCT00048451 COMPLETED PHASE3
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
NCT01785849 COMPLETED PHASE3
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
NCT00701805 COMPLETED PHASE2
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
NCT01479088 UNKNOWN PHASE2/PHASE3
A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism
NCT04994080 UNKNOWN PHASE3