Renal OsteodystrophyPhase 2NCT00004340
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
A Phase 2 study testing calcitriol and growth hormone in people with Renal Osteodystrophy and End Stage Renal Disease, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Renal Osteodystrophy, End Stage Renal Disease
- What is being tested?
- calcitriol and growth hormone
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1995to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles
--Prior/Concurrent Therapy--
- No concurrent prednisone
- No concurrent cytotoxic agents
- At least 12 months since parathyroidectomy
--Patient Characteristics--
- Other: No documented history of poor compliance with medical treatment regimens
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles School of Medicine
Los Angeles, California, 90095
About this study
OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.
II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation.
III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism.
Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months.
Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week.
Patients in the third group are treated with growth hormone and calcitriol (same dosages as above).
A control group does not receive any hormonal therapy.
- Conditions
- Renal Osteodystrophy, End Stage Renal Disease
- Being tested
- calcitriol, growth hormone
- Keywords
- end stage renal disease, rare disease, renal and genitourinary disorders, renal osteodystrophy
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Kidney Failure, Chronic, Rare Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDrug
growth hormoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJun 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal OsteodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 109 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles
- Investigators
- Isidro B. Salusky, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004340
- Sponsor's protocol ID
- 199/11899
- Other IDs
- UCLA-612
- Status last verified
- Apr 2002
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
- ClinicalTrials.gov ID
- NCT00004340
- Acronym / sponsor ID
- 199/11899
- Conditions
- Renal Osteodystrophy, End Stage Renal Disease
- Keywords
- end stage renal disease, rare disease, renal and genitourinary disorders, renal osteodystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles
- Study start
- Jun 1995
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.
II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation.
III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism.
Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months.
Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week.
Patients in the third group are treated with growth hormone and calcitriol (same dosages as above).
A control group does not receive any hormonal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcitriol | Drug | – |
| growth hormone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isidro B. Salusky study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing calcitriol and growth hormone in people with Renal Osteodystrophy and End Stage Renal Disease, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.