End Stage Renal DiseasePhase 2NCT00381602
A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis
A Phase 2 study testing GHRP-1/AG 70 mg depot in ESRD in people with End Stage Renal Disease, run by QLT Inc. at 2 sites in United States.
Trial summary
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- GHRP-1/AG 70 mg depot in ESRD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to May 2007
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ESRD who have been on HD for at least 3 months and have a urea reduction rate (URR) of at least 65%.
- Subjects who are 18 to 70 years of age.
- Subjects who have a body mass index (BMI) less than 30, albumin greater than 3.3 g/dL, and MIS of 5 to 10 (inclusive).
Who cannot join
- Subjects who have diabetes and are currently taking insulin.
- Subjects who have a history of or current significant central nervous system (CNS) disorders.
- Subjects who have active infection at baseline.
- Subjects who have active or unstable cardiac or arterial disease.
- Subjects who have uncontrolled tertiary hyperparathyroid condition.
- Subjects who have anemia.
- Subjects who have a history of hepatitis or current liver disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tulane University Medical School
New Orleans, Louisiana, 70112
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric intake.
Read the detailed description
This is a randomized, cross-over, double-blind, vehicle-controlled study. Subjects will receive single subcutaneous injections of the active GHRP-1/AG study treatment and vehicle control (ATRIGEL delivery system) in a randomized sequence. Each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up. Treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule. The total duration of study participation will be 12 weeks. Safety will be followed throughtout the study with vital signs, electrocardiogram, clinical chemistry and hematology parameters, endocrine parameters, adverse events, and concomitant medications. PD effects of GHRP-1/AG will be evaluated by measuring GH, ICF-1, IGF-BP3, prolactin, and cortisol. Efficacy will be evaluated throughout the study with MIS, caloric intake, nPCR, dry weight, BMI, and albumin, BUN, creatinine, calcium, potassium, HGB, HCT, and CBC.
- Conditions
- End Stage Renal Disease
- Being tested
- GHRP-1/AG 70 mg depot in ESRD, Placebo
- Keywords
- End stage renal disease, Hemodialysis, Malnutrition, End stage renal disease (ESRD)
- Medical subject headings
- Kidney Failure, Chronic, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHRP-1/AG 70 mg depot in ESRDDrug
PlaceboOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
ECG
clinical chemistry and hematology
MIS
caloric intake (protein, fat, carbohydrates, total)
nPCR
BMI and dry weight
clinical laboratory parameters
Secondary outcomes (5)
IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations
GHRP-1 and des-Ala-GHRP-1 plasma concentrations
adverse events
concomitant medications
endocrine parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: Lack of enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- QLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Graeme R Boniface, Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381602
- Sponsor's protocol ID
- GHRP ESRD 01
- Status last verified
- Mar 2011
- First submitted
- 26 Sep 2006
- Last updated
- 4 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis
- ClinicalTrials.gov ID
- NCT00381602
- Acronym / sponsor ID
- GHRP ESRD 01
- Conditions
- End Stage Renal Disease
- Keywords
- End stage renal disease, Hemodialysis, Malnutrition, End stage renal disease (ESRD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrolment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- QLT Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 28 Sep 2006 (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.
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric intake.
Detailed description
This is a randomized, cross-over, double-blind, vehicle-controlled study. Subjects will receive single subcutaneous injections of the active GHRP-1/AG study treatment and vehicle control (ATRIGEL delivery system) in a randomized sequence. Each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up. Treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule. The total duration of study participation will be 12 weeks. Safety will be followed throughtout the study with vital signs, electrocardiogram, clinical chemistry and hematology parameters, endocrine parameters, adverse events, and concomitant medications. PD effects of GHRP-1/AG will be evaluated by measuring GH, ICF-1, IGF-BP3, prolactin, and cortisol. Efficacy will be evaluated throughout the study with MIS, caloric intake, nPCR, dry weight, BMI, and albumin, BUN, creatinine, calcium, potassium, HGB, HCT, and CBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with ESRD who have been on HD for at least 3 months and have a urea reduction rate (URR) of at least 65%.
- Subjects who are 18 to 70 years of age.
- Subjects who have a body mass index (BMI) less than 30, albumin greater than 3.3 g/dL, and MIS of 5 to 10 (inclusive).
Key exclusion criteria (7 listed)
- Subjects who have diabetes and are currently taking insulin.
- Subjects who have a history of or current significant central nervous system (CNS) disorders.
- Subjects who have active infection at baseline.
- Subjects who have active or unstable cardiac or arterial disease.
- Subjects who have uncontrolled tertiary hyperparathyroid condition.
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 |
|---|---|---|
| GHRP-1/AG 70 mg depot in ESRD | Drug | – |
| Placebo | Other | – |
Primary outcome
Vital signs
ECG
clinical chemistry and hematology
MIS
caloric intake (protein, fat, carbohydrates, total)
nPCR
BMI and dry weight
clinical laboratory parameters
5 secondary outcomes
IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations
GHRP-1 and des-Ala-GHRP-1 plasma concentrations
adverse events
concomitant medications
endocrine parameters
Results and safety
The study was stopped early (reason given: Lack of enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
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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.
Graeme R Boniface study director
QLT Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GHRP-1/AG 70 mg depot in ESRD in people with End Stage Renal Disease, run by QLT Inc. at 2 sites 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?
The sponsor lists 3 inclusion and 7 exclusion criteria. 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: stopped early, as of the sponsor's last update on 4 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Lack of enrolment). Results are not available in the source record.
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.
What does the primary outcome measure?
Vital signs. The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 4 Apr 2011.