Trial Outcomes & Findings for Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients (NCT NCT00646282)

Results Overview

Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

18 months

Results posted on

2015-01-26

Participant Flow

Subjects were enrolled from July 2008 to February 2009

Four of the 12 subjects that were consented were withdrawn because they did not meet inclusion criteria or met exclusion criteria.

Participant milestones

Participant milestones
Measure	Doxercalciferol Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH\>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH \<300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.	Control Stable kidney transplant recipients do not receive any drug.
Overall Study STARTED	4	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxercalciferol Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH\>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH \<300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.	Control Stable kidney transplant recipients do not receive any drug.
Overall Study Protocol terminated	4	4

Baseline Characteristics

Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxercalciferol n=4 Participants Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH\>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH \<300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.	Control n=4 Participants Stable kidney transplant recipients do not receive any drug	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Data not analyzed due to study termination

Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months

Outcome measures

Outcome data not reported

Adverse Events

Doxercalciferol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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. Antonio Guasch

Emory University

Phone: 404-727-2522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place