Adrenal InsufficiencyNCT03136562
Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment
An observational study of Adrenal Insufficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary purpose of this study is to determine the prevalence of adrenal insufficiency in a population of patients with kidney transplants receiving low dose prednisone treatment. Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to glucocorticoid treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Synacthen test
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Mar 2017to 1 Jun 2019
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: 30 kidney transplanted patients and 30 patients in dialysis.
Who may be able to join
- Adult patients (>18 years).
- Kidney transplated patients or patients with kidney failure treated in dialysis.
- Prednisone min 5 mg/day max 7,5 mg/day for the kidney transplanted patients (control group not treated with prednisone).
Who cannot join
- Other major organ disease.
- Anemia with hemoglobin level less than 6,5 mmol/L.
- Not willing to pause any oestrogen tratment for a minimum of 6 weeks.
- Pregnancy.
- Not understanding Danish language or otherwise not able to provide a written informed concent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients (NTx) in Glucocorticoid Treatment
The primary purpose of this study is to determine the prevalence of adrenal insufficiency in a population of patients with kidney transplants receiving low dose prednisone treatment.
Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to glucocorticoid treatment. The study includes a control group of patients with kidney failure currently treated in dialysis, who are not in glucocorticoid treatment.
Read more
Individual genotyping is performed to determine the haplotype of glucocorticoid receptor polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid receptor gene will either have increased or diminished glucocorticoid sensitivity.
Using validated questionnaires assessing the quality of life and functional level of the patients enrolled in the study we aim to establish a link between functional level and biochemically proven adrenal insufficiency.
Other secondary outcomes in the study includes bloodpressure, body composition, bone density, metabolic syndrome, inflammation and salivary cortisol profiles.
Read the detailed description
Adrenal function is assessed in 30 prednisolon treated kidney transplanted patients and compared with 30 patients in dialysis, who are not treated with glucocorticoids. Adrenal function is evaluated using a 250µg Synacthen® test, performed fasting, in the morning, 48 h after the last prednisolone dose.
Cut-off for normal adrenal function is locally validated assay specific cut-off of 30 min P-cortisol >420 nmol/l. The primary outcome measure of this study is P-cortisol concentrations 30 minutes after Synacthen® injection in prednisolone treated patients compared with comtrols. Secondary, 30 minutes P-cortisol is examined in relation to glucocorticoid receptor haplotypes.
The genotyping is determined using polymerase chain reaction (PCR).
The questionnaires used in this study includes EQ-5D, SF-36, Patient Life Situation Form, CushingQol and ADDOQol.
- Conditions
- Adrenal Insufficiency
- Being tested
- Synacthen test
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synacthen testDiagnostic test
250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplanted patients | Kidney transplanted patients in prednisolone treatment. Adrenal function is assessed by a synacthen test. Receives: Diagnostic Test: Synacthen test | |
| Control group | Patients in dialysis not in prednisolone treatment. Adrenal function is assessed by a synacthen test. Receives: Diagnostic Test: Synacthen test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is the result of the Synacthen® test using primarily the level of P-cortisol 30 minutes after the injection of synacthen.
Cutoff for normal adrenal function: 30 min p-cortisol >/= 420 nmol/L.
Measured: The time frame of each Synacthen® test is approximately 90 minutes.
Secondary outcomes (7)
Registration of history of treatment.
History of treatment with prednisone and other types of glucocorticoids to examine dosage and time of treatment as risk factors.
Measured: The registration will take place at the study visit (approximately 90 minutes).
Quality of life and functional level.
Assessed in all patients enrolled in the study using validated questionnaires as a means to establish a link between functional level and biochemically proven adrenal insufficiency.
Measured: Patients receive and fill out the questionnaires prior to their arrival at the study visit and hand them in after the Synacthen® test. Patients receive questionnaires either by mail or at one of their visits in the out patient clinic.
Determination of the specific type of glucocorticoid receptor using genotyping in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency.
Patients are genotyped for 4 polymorphisms (9 beta, ER22/23EK, Bcl1 and N363S) of the glucocorticoid receptor.
Measured: Blood for genotyping is sampled from each patient at the study visit during the Synacthen® test. The blood samples are stored frozen and analyzed concurrently.
Body composition
Height, weight, waist and hip circumference.
Measured: After the Synacthen® test the height, weight, waist and hip circumference are measured at the study visit.
Bone density.
Results from Dxa-scan.
Measured: The results from latest Dxa-scan performed in rutine settings are collected from the patients on the same day as the Synacthen® test.
Metabolic syndrome.
Waistline, triglyceride level, HDL cholesterol level, blood pressure and fasting blood sugar is assessed in all the patients.
Measured: The waistline and blood pressure are measured at the study visit after the Synacthen® test. The blood samples are collected as part of the test and analyazed on the same day.
Salivary cortisol profiles.
Cortisol concentration in saliva.
Measured: Saliva is sampled from each patient at the study visit as part of the Synacthen® test. The samples are stored frozen and analyzed concurrently after all 60 Synacthen® tests have been performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start20 Mar 2017
- Primary completion1 Feb 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulla Feldt-Rasmussen, Professor, Principal investigator, Department of Endocrinology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136562
- Sponsor's protocol ID
- NTx-CSI
- Status last verified
- Apr 2023
- First submitted
- 21 Feb 2017
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients (NTx) in Glucocorticoid Treatment
- ClinicalTrials.gov ID
- NCT03136562
- Acronym / sponsor ID
- NTx-CSI
- Conditions
- Adrenal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
The primary purpose of this study is to determine the prevalence of adrenal insufficiency in a population of patients with kidney transplants receiving low dose prednisone treatment.
Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to glucocorticoid treatment. The study includes a control group of patients with kidney failure currently treated in dialysis, who are not in glucocorticoid treatment.
Individual genotyping is performed to determine the haplotype of glucocorticoid receptor polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid receptor gene will either have increased or diminished glucocorticoid sensitivity.
Using validated questionnaires assessing the quality of life and functional level of the patients enrolled in the study we aim to establish a link between functional level and biochemically proven adrenal insufficiency.
Other secondary outcomes in the study includes bloodpressure, body composition, bone density, metabolic syndrome, inflammation and salivary cortisol profiles.
Detailed description
Adrenal function is assessed in 30 prednisolon treated kidney transplanted patients and compared with 30 patients in dialysis, who are not treated with glucocorticoids. Adrenal function is evaluated using a 250µg Synacthen® test, performed fasting, in the morning, 48 h after the last prednisolone dose.
Cut-off for normal adrenal function is locally validated assay specific cut-off of 30 min P-cortisol >420 nmol/l. The primary outcome measure of this study is P-cortisol concentrations 30 minutes after Synacthen® injection in prednisolone treated patients compared with comtrols. Secondary, 30 minutes P-cortisol is examined in relation to glucocorticoid receptor haplotypes.
The genotyping is determined using polymerase chain reaction (PCR).
The questionnaires used in this study includes EQ-5D, SF-36, Patient Life Situation Form, CushingQol and ADDOQol.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney transplanted patients | – | Diagnostic Test: Synacthen testKidney transplanted patients in prednisolone treatment. Adrenal function is assessed by a synacthen test. |
| Control group | – | Diagnostic Test: Synacthen testPatients in dialysis not in prednisolone treatment. Adrenal function is assessed by a synacthen test. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 30 kidney transplanted patients and 30 patients in dialysis.
Key inclusion criteria (3 listed)
- Adult patients (>18 years).
- Kidney transplated patients or patients with kidney failure treated in dialysis.
- Prednisone min 5 mg/day max 7,5 mg/day for the kidney transplanted patients (control group not treated with prednisone).
Key exclusion criteria (5 listed)
- Other major organ disease.
- Anemia with hemoglobin level less than 6,5 mmol/L.
- Not willing to pause any oestrogen tratment for a minimum of 6 weeks.
- Pregnancy.
- Not understanding Danish language or otherwise not able to provide a written informed concent.
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 |
|---|---|---|
| Synacthen test250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection. | Diagnostic test | Control group, Kidney transplanted patients |
Primary outcome
The primary outcome measure of this study is the result of the Synacthen® test using primarily the level of P-cortisol 30 minutes after the injection of synacthen.
Time frame: The time frame of each Synacthen® test is approximately 90 minutes.
Cutoff for normal adrenal function: 30 min p-cortisol >/= 420 nmol/L.
7 secondary outcomes
Registration of history of treatment.
Time frame: The registration will take place at the study visit (approximately 90 minutes).
Quality of life and functional level.
Time frame: Patients receive and fill out the questionnaires prior to their arrival at the study visit and hand them in after the Synacthen® test. Patients receive questionnaires either by mail or at one of their visits in the out patient clinic.
Determination of the specific type of glucocorticoid receptor using genotyping in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency.
Time frame: Blood for genotyping is sampled from each patient at the study visit during the Synacthen® test. The blood samples are stored frozen and analyzed concurrently.
Body composition
Time frame: After the Synacthen® test the height, weight, waist and hip circumference are measured at the study visit.
Bone density.
Time frame: The results from latest Dxa-scan performed in rutine settings are collected from the patients on the same day as the Synacthen® test.
Metabolic syndrome.
Time frame: The waistline and blood pressure are measured at the study visit after the Synacthen® test. The blood samples are collected as part of the test and analyazed on the same day.
Salivary cortisol profiles.
Time frame: Saliva is sampled from each patient at the study visit as part of the Synacthen® test. The samples are stored frozen and analyzed concurrently after all 60 Synacthen® tests have been performed.
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 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ulla Feldt-Rasmussen, Professor principal investigator
Department of Endocrinology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 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 7 Apr 2023. 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 Denmark. 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.
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?
The primary outcome measure of this study is the result of the Synacthen® test using primarily the level of P-cortisol 30 minutes after the injection of synacthen. (time frame: The time frame of each Synacthen® test is approximately 90 minutes.). 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 7 Apr 2023.