SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

cinacalcet

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Clinical trial, Amgen, Secondary HyperParaThyroidism (SHPT), Dialysis, End Stage Renal Disease (ESRD), KDOQI, Cinacalcet

Eligibility Criteria

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

Inclusion Criteria: - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL [2.1 mmol/L] Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

During dialysis visit

Post-dialysis meal

Arm Description

Cinacalcet is given during the dialysis visit

Cinacalcet is administered with a post-dialysis meal

Outcomes

Primary Outcome Measures

Number of subjects with PTH less than or equal to 300pg/mL

Secondary Outcome Measures

Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes

Safety of cinacalcet

Full Information

NCT ID

NCT00117052

First Posted

June 30, 2005

Last Updated

May 21, 2013

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00117052

Brief Title

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

Official Title

SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Hyperparathyroidism, End Stage Renal Disease

Keywords

Clinical trial, Amgen, Secondary HyperParaThyroidism (SHPT), Dialysis, End Stage Renal Disease (ESRD), KDOQI, Cinacalcet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

673 (Actual)

8. Arms, Groups, and Interventions

Arm Title

During dialysis visit

Arm Type

Active Comparator

Arm Description

Cinacalcet is given during the dialysis visit

Arm Title

Post-dialysis meal

Arm Type

Active Comparator

Arm Description

Cinacalcet is administered with a post-dialysis meal

Intervention Type

Drug

Intervention Name(s)

cinacalcet

Intervention Description

All eligible subjects were assigned to receive once daily oral doses of cinacalcet, but were randomised in a 1:1 ratio to receive the drug either with the first meal after dialysis or during the dialysis visit on dialysis days.

Primary Outcome Measure Information:

Title

Number of subjects with PTH less than or equal to 300pg/mL

Time Frame

21 week dose optimisation phase

Secondary Outcome Measure Information:

Title

Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes

Time Frame

Dose Optimisation phase 21 weeks

Title

Safety of cinacalcet

Time Frame

21 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL [2.1 mmol/L] Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MD

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

18793528

Citation

Schaefer RM, Bover J, Dellanna F, Sanz D, Asensio C, Sanchez Gonzalez MC, Gross P, Zani V, Carter D, Jehle PM. Efficacy of cinacalcet administered with the first meal after dialysis: the SENSOR Study. Clin Nephrol. 2008 Aug;70(2):126-34. doi: 10.5414/cnp70126.

Results Reference

result

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

URL

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Description

Notice regarding posted summaries of trial results

URL

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_38_AMG_073_20040143.pdf

Description

To access clinical trial results information click on this link

URL

http://www.sensipar.com/

Description

FDA-approved Drug Labeling

Secondary Hyperparathyroidism, End Stage Renal Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial