Trial Outcomes & Findings for Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria (NCT NCT00625820)

NCT ID: NCT00625820

Last Updated: 2016-10-18

Results Overview

Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-10-18

Participant Flow

Patients were recruited from nephrology clinics based on baseline estimated glomerular filtration rate (eGFR). Informed consent was obtained from each patient prior to the study based on institutional review board (IRB) approved guidelines.

Seventeen patients were recruited and all started the trial.

Participant milestones

Measure	1BH4, BH4 + Vitamin C N/A Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	1BH4, BH4 + Vitamin C N/A Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria

Baseline characteristics by cohort

Measure	1BH4, BH4 + Vitamin C n=17 Participants NA Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	59.9 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All participants who finished the trial were analyzed

Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.

Outcome measures

Measure	1BH4, BH4 + Vitamin C n=16 Participants
The Primary Outcome Measure is Level of Albuminuria. Albuminuria at week 6	927.9 ratio Standard Deviation 244.9
The Primary Outcome Measure is Level of Albuminuria. Albuminuria at week 12	897.1 ratio Standard Deviation 217.9

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	1BH4, BH4 + Vitamin C n=16 Participants
Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy. Systolic Blood Pressure at week 6	143.1 mmHG Standard Deviation 5.1
Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy. Systolic Blood Pressure at week 12	134.1 mmHG Standard Deviation 3.71

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	1BH4, BH4 + Vitamin C n=16 Participants
Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy. eGFR at week 6	68.1 ml/min/1.73m2 Standard Deviation 6.7
Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy. eGFR at week 12	70.8 ml/min/1.73m2 Standard Deviation 6.4

Adverse Events

BH4, BH4 + Vit C

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BH4, BH4 + Vit C n=17 participants at risk
Renal and urinary disorders Nephrolithiasis	5.9% 1/17 • Number of events 1

Additional Information

Rajiv Saran, MD

University of Michigan

Phone: 734-763-6611

Email: rsaran@umich.edu

Results disclosure agreements

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