Chronic Kidney DiseasePhase 1NCT01502137
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
A Phase 1 study testing somatropin in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Disease, Healthy
- What is being tested?
- somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2005to Nov 2005
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENTS:
- Male or female, age equal to or above 18 years undergoing chronic haemodialysis
- Stable and adequate haemodialysis treatment three months prior to enrolment
- HEALTHY SUBJECTS:
- Matching an individual of the patient group by: Gender and age (± 5 years)
- Matching an individual of the patient group by weight (after dialysis, ±10%)
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- Creatinine clearance above 80 ml/min
- Subjects must be in good health in accordance with their age as determined by a medical
- history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry
Who cannot join
- Use of cuprophane membranes
- Active malignant disease
- Diabetes
- Critical illness as defined by the need of respiratory or circulatory support
- Known or suspected allergy to the trial product
- Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
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- using inadequate contraceptive measures
- Blood Pressure (pre-dialysis) above 180/110
- Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
- Treated with immunosuppressive agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease, Healthy
- Being tested
- somatropin
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, patients will receive 8 doses.
somatropinDrug
Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, subjects will receive 7 doses.
| Study group | Role | What they receive |
|---|---|---|
| ESRD patients | Experimental | Not described Receives: Drug: somatropin |
| Healthy subjects | Experimental | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone exposure at steady state
Secondary outcomes (6)
Area under the Curve (AUC)
t½ (terminal half-life)
Cmax (maximum plasma concentration)
tmax (time to reach maximum)
IGF-I (Insulin-Like Growth Factor I)
Adverse events (AE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJun 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502137
- Sponsor's protocol ID
- NN1630-1559
- Other IDs
- 2005-000765-19, 2005
- Status last verified
- Jan 2017
- First submitted
- 29 Dec 2011
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Langbakke IH, Nielsen JN, Skettrup MP, Harper A, Klitgaard T, Weil A, Engelhardt E, Lange M. Pharmacokinetics and pharmacodynamics of growth hormone in patients on chronic haemodialysis compared with matched healthy subjects: an open, nonrandomized, parallel-group trial. Clin Endocrinol (Oxf). 2007 Nov;67(5):776-83. doi: 10.1111/j.1365-2265.2007.02962.x. Epub 2007 Jul 18.
PubMed 17634080
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects
- ClinicalTrials.gov ID
- NCT01502137
- Acronym / sponsor ID
- NN1630-1559
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 30 Dec 2011 (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.
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD patients | Experimental | Drug: somatropin |
| Healthy subjects | Experimental | Drug: somatropin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PATIENTS:
- Male or female, age equal to or above 18 years undergoing chronic haemodialysis
- Stable and adequate haemodialysis treatment three months prior to enrolment
- HEALTHY SUBJECTS:
- Matching an individual of the patient group by: Gender and age (± 5 years)
Key exclusion criteria (10 listed)
- Use of cuprophane membranes
- Active malignant disease
- Diabetes
- Critical illness as defined by the need of respiratory or circulatory support
- Known or suspected allergy to the trial product
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 |
|---|---|---|
| somatropinInjected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, patients will receive 8 doses. | Drug | ESRD patients |
| somatropinInjected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, subjects will receive 7 doses. | Drug | Healthy subjects |
Primary outcome
Growth hormone exposure at steady state
6 secondary outcomes
Area under the Curve (AUC)
t½ (terminal half-life)
Cmax (maximum plasma concentration)
tmax (time to reach maximum)
IGF-I (Insulin-Like Growth Factor I)
Adverse events (AE)
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 Jan 2017.
- Results publication: PubMed 17634080Langbakke IH, Nielsen JN, Skettrup MP, Harper A, Klitgaard T, Weil A, Engelhardt E, Lange M. Pharmacokinetics and pharmacodynamics of growth hormone in patients on chronic haemodialysis compared with matched healthy subjects: an open, nonrandomized, parallel-group trial. Clin Endocrinol (Oxf). 2007 Nov;67(5):776-83. doi: 10.1111/j.1365-2265.2007.02962.x. Epub 2007 Jul 18.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing somatropin in people with Chronic Kidney Disease and End-Stage Renal Disease, run by Novo Nordisk A/S at 1 site in Germany.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 24 Jan 2017. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Growth hormone exposure at steady state. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502137, which also lists 1 linked publication.
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 Jan 2017.