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

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Brief Title

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

Official Title

IGF-1 Generation Test in Children With Chronic Kidney Disease

Brief Summary

      Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has
      been shown to be helpful in treating children with chronic kidney disease who fail to grow.
      The amount of growth that is seen in children treated with growth hormone varies widely for
      unknown reasons. Growth hormone works by producing another hormone in the liver called
      insulin-like growth factor-1, or IGF-1 for short. IGF-1 stimulates the bones to grow. The
      amount of IGF-1 in the blood may directly affect the amount of growth in each child. At this
      time, growth hormone therapy in children depends on giving a certain dose of growth hormone
      for each child based on his or her weight. If after 3-6 months on this dose of growth hormone
      the change in height is not enough, then the dose of growth hormone is increased until enough
      growth is seen. This method of dosing of growth hormone may take a long time and is
      complicated and time-consuming.

      The purpose of this study is to measure the amount of IGF-1 produced by the body as a result
      of giving 2 different doses of growth hormone in children for 7 days only. The study
      investigator hopes to find the most favorable level of IGF-1 generated after 7 days of growth
      hormone that correlates with good growth of children with kidney disease. Then instead of
      dosing growth hormone by weight, like is done now, researchers can dose growth hormone by the
      amount of IGF-1 that the body produces. Being able to dose more effectively will save
      valuable time for the child to grow and will shorten the overall duration of growth hormone
      therapy.

      The investigators will also determine the effect of inflammatory cytokines Il-6 and TNF-alpha
      on growth hormone insensitivity and hence IGF-1 generation test in the same population.
    

Detailed Description

      The study will involve 30 children with chronic kidney disease and failure to grow. The study
      will last for 14 months. There will be a screening clinic visit if the child qualifies for
      the study, Week -8. Each clinic visit will include, getting a medical history, a physical
      exam, and a blood test. Also an x-ray of the wrist to calculate bone age. If abnormal blood
      values are found as a result of kidney failure then an attempt will be made to correct them
      over the next 2 months before enrollment in the study.

      Also children will be asked to keep track of all of the foods for 3 days every month during
      the study. A study nutritionist will call them once each month to go over the food diary.

      At study Week -4, children will come again for a clinic visit. Then at Week 0 of the study, a
      decision will be made randomly based on the level of kidney function to what dose of growth
      hormone a child will receive. This will be either a low dose of growth hormone or a high dose
      of growth hormone.

      At the Week 1 and Week 4 visits, children will come for a clinic visit. Children will take
      growth hormone (through a needle under the skin) every night for a full 7 days during each of
      the two weeks. In the mornings before the 1st and after the 7th dose both weeks, children
      will have their blood drawn to check IGF-1 levels.

      During Weeks 2 and 3, children will not take any growth hormone in order to allow the body to
      clear, or "wash-out", the medication from the system before Week 4.

      At Week 5, children will begin taking growth hormone each evening and continue to do so every
      day through Week 28. Then, for Weeks 29 and 30, children will have another "wash-out" period
      with no growth hormone treatment.

      At Week 31, blood will be drawn in the mornings before the 1st and after the 7th dose of
      growth hormone treatment. From Week 32 on, children will take growth hormone every evening
      and continue to do so through Week 56, the end of the study.

      Also at week 1, skin fold measurements to assess body fat will be done on all subjects. A
      DEXA scan, a test that measures body fat and muscle mass will be done on the older children
      in the study on an optional basis on Weeks 1, 28 and 56. Another wrist X-ray for bone age
      will be repeated at 56 weeks of the study.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)

Secondary Outcome

 Change in Height at 56 Weeks

Condition

Kidney Failure, Chronic

Intervention

Nutropin AQ

Study Arms / Comparison Groups

 Low- Standard GH dose
Description:  This arm will receive Low dose of growth hormone (GH) (Nutropin AQ), for 7 days in a cross over design. Low dose GH will be 0.025 mg/kg/day. This will be followed by 2 weeks of wash out, then subjects will receive and the standard dose of Nutropin AQ (GH) at 0.05 mg/kg/dose given subcutaneously for another 7 days. IGF-I levels are measured after 7 days of the Low and the Standard dose of GH. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months and re-evaluated. If growth is adequate then subjects will continue on standard dose of GH for another 6 months for a total of 12 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

17

Start Date

January 2005

Completion Date

May 2010

Primary Completion Date

May 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Males and females between 2-18 years of age with chronic renal failure.

          -  Estimated creatinine clearance between 25-75 ml/min/1.73 m2 calculated by the Schwartz
             formula.

          -  Height standard deviation score (SDS) more than -1.88 or annual height velocity SD of
             more than -2.0 for age and sex for the preceding 6 months.

          -  No history of growth hormone therapy.

          -  Cystinosis subjects may qualify for the study if they meet other inclusion criteria
             and have an estimated creatinine clearance of 25-75 ml/min/1.73 m2.

          -  Bone age less than 16 years for boys and less than 13 years for girls.

          -  Subjects with chronic kidney failure who are off steroid therapy or other drugs that
             interfere with growth for at least 6 months.

        Exclusion Criteria:

          -  Subjects on dialysis and kidney transplant recipients.

          -  Patients with significant renal osteodystrophy or an intact parathyroid (PTH) level
             more than 500 pg/ml over the last 3 months prior to enrollment.

          -  Diabetes mellitus.

          -  History of malignancy.
      

Gender

All

Ages

2 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Amira Y Al-Uzri, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00212758

Organization ID

Genentech # 303-MO1


Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University

Collaborators

 Genentech, Inc.

Study Sponsor

Amira Y Al-Uzri, M.D., Principal Investigator, Oregon Health and Science University


Verification Date

October 2011