Trial Outcomes & Findings for A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood (NCT NCT00212758)

NCT ID: NCT00212758

Last Updated: 2011-10-26

Results Overview

We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: Day 1 & Day 8
• Results posted on: 2011-10-26

Participant Flow

This is a multicenter trial. Patients were recruited from pediatric nephrology clinics at various centers.

A two month run-in period was implemented to stabilize subjects and correct any metabolic abnormalities that may affect growth. This two month period may be waived per the center PI if patient was deemed stable. Patients were randomized to either a low or standard dose of GH (Nutropin AQ)used in the IGF-I generation.

Participant milestones

Measure	Low-standard-standard GH This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.	Standard- Low- Standard GH This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
First Intervention (7 Days) STARTED	8	9
First Intervention (7 Days) COMPLETED	8	9
First Intervention (7 Days) NOT COMPLETED	0	0
Wash Out Period (2 Weeks) STARTED	8	9
Wash Out Period (2 Weeks) COMPLETED	8	9
Wash Out Period (2 Weeks) NOT COMPLETED	0	0
Second Intervention (7 Days) STARTED	8	9
Second Intervention (7 Days) COMPLETED	8	9
Second Intervention (7 Days) NOT COMPLETED	0	0
Standard Therapy of GH (12 Months) STARTED	8	9
Standard Therapy of GH (12 Months) COMPLETED	6	8
Standard Therapy of GH (12 Months) NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Low-standard-standard GH This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.	Standard- Low- Standard GH This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
Standard Therapy of GH (12 Months) Adverse Event	1	0
Standard Therapy of GH (12 Months) Lost to Follow-up	1	1

Baseline Characteristics

A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood

Baseline characteristics by cohort

Measure	All Participants n=17 Participants Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
Age, Categorical <=18 years	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	7.6 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 & Day 8

We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).

Outcome measures

Measure	Low Dose GH n=6 Participants Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.	Standard Dose GH n=8 Participants Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)	115 mcg/L Standard Deviation 104	129 mcg/L Standard Deviation 112

SECONDARY outcome

Timeframe: week 1, week 56

Outcome measures

Measure	Low Dose GH n=14 Participants Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.	Standard Dose GH Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
Change in Height at 56 Weeks	10.3 cm Standard Deviation 1.1	—

Adverse Events

All Participants

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. Amira Al-Uzri

Oregon Health & Science University

Phone: 503-494-7327

Email: aluzria@ohsu.edu

Results disclosure agreements

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

Restriction type: LTE60