Trial Outcomes & Findings for The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate (NCT NCT01163162)

NCT ID: NCT01163162

Last Updated: 2013-05-21

Results Overview

We expect the 24 hour urine creatinine excretion rate to show no differences between groups.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 1 Week
• Results posted on: 2013-05-21

Participant Flow

Participant milestones

Measure	Paricalcitol After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate

Baseline characteristics by cohort

Measure	Paricalcitol n=16 Participants After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
Age Continuous	69.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Week

We expect the 24 hour urine creatinine excretion rate to show no differences between groups.

Outcome measures

Measure	Paricalcitol n=16 Participants After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
24-hour Urine Creatinine Excretion Rate	17.6 mg/24hour/day Interval 0.5 to 34.6

SECONDARY outcome

Timeframe: 1 Week

The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.

Outcome measures

Measure	Paricalcitol n=16 Participants After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
Creatinine Clearance	0.49 ml/min Interval -0.26 to 1.23

SECONDARY outcome

Timeframe: 1 Week

We expect serum creatinine to confirm the results of creatinine clearance.

Outcome measures

Measure	Paricalcitol n=16 Participants After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
Serum Creatinine	0.010 mg/dl/day Interval 0.001 to 0.019

Adverse Events

Paricalcitol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Paricalcitol n=16 participants at risk After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
General disorders Dizziness	12.5% 2/16 • Number of events 2
General disorders Skin irritation	6.2% 1/16 • Number of events 1

Additional Information

Dr. Rajiv Agarwal

Indiana University

Phone: 317 988 2241

Email: ragarwal@iu.edu

Results disclosure agreements

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