Trial Outcomes & Findings for Trial to Optimize Mineral Outcomes in Dialysis Patients (NCT NCT01100723)

NCT ID: NCT01100723

Last Updated: 2017-01-02

Results Overview

Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 92 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-01-02

Participant Flow

181 pts in dialysis center. 65 did not meet enrollment criteria. 23 declined participation and 1 had prior intolerance to cinacalcet. Therefore 92 subjects enrolled in study.

No washout. Once enrolled, mineral and bone disorder managed by computer algorithm.

Participant milestones

Measure	Post Treatment Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
Overall Study STARTED	92
Overall Study 6 Month Analysis	85
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Optimize Mineral Outcomes in Dialysis Patients

Baseline characteristics by cohort

Measure	Post Treatment n=92 Participants Results analyzed at study evaluation time points.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Gender Female	40 Participants n=5 Participants
Gender Male	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Subjects who had at least one laboratory measurement during the assessment phase.

Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

Outcome measures

Measure	Post Treatment n=78 Participants Results analyzed at study evaluation time points.
Percent of Patients Achieving Parathyroid Hormone Target ≤ 300	21 percentage of subjects meeting target

PRIMARY outcome

Timeframe: 1 year

Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

Outcome measures

Measure	Post Treatment n=78 Participants Results analyzed at study evaluation time points.
Percent of Patients Achieving Phosphorous Target ≤ 5.5	53 percent of participants in target

SECONDARY outcome

Timeframe: 1 year

Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

Outcome measures

Measure	Post Treatment n=78 Participants Results analyzed at study evaluation time points.
Percent of Patients Achieving Parathyroid Hormone Target ≤ 450	33 percent of participants in target

SECONDARY outcome

Timeframe: 1 year

Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

Outcome measures

Measure	Post Treatment n=78 Participants Results analyzed at study evaluation time points.
Percent of Patients Achieving Phosphorous Target ≤ 4.5	29 percent of participants in target

SECONDARY outcome

Timeframe: 1 year

Population: Subjects with at least one laboratory value during evaluation period.

Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

Outcome measures

Measure	Post Treatment n=78 Participants Results analyzed at study evaluation time points.
Percent of Patients Achieving Calcium Target ≤ 10.1	78 percentage of subjects in target

SECONDARY outcome

Timeframe: 6 months and 1 year

Population: Number of subjects with at least 1 laboratory analysis during the evaluation period.

Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and at 6 and 12 months after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.

Outcome measures

Measure	Post Treatment n=78 Participants Results analyzed at study evaluation time points.
Percent of Patients on Cinacalcet and Vitamin D Analogues	84 percentage of subjects receiving med

Adverse Events

Post Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David M. Spiegel

University of Colorado

Phone: 303-724-7797

Email: david.spiegel@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place