- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136562
Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Ulla Feldt-Rasmussen, Professor
- Phone Number: +45 35451023
- Email: ufeldt@rh.dk
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Kidney transplanted patients
Kidney transplanted patients in prednisolone treatment.
Adrenal function is assessed by a synacthen test.
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250 microg synacthen test performed fasting, in the morning.
P-cortisol measured before and 30 minutes after Synacthen injection.
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Control group
Patients in dialysis not in prednisolone treatment.
Adrenal function is assessed by a synacthen test.
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250 microg synacthen test performed fasting, in the morning.
P-cortisol measured before and 30 minutes after Synacthen injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Cutoff for normal adrenal function: 30 min p-cortisol >/= 420 nmol/L.
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The time frame of each Synacthen® test is approximately 90 minutes.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Registration of history of treatment.
Time Frame: The registration will take place at the study visit (approximately 90 minutes).
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History of treatment with prednisone and other types of glucocorticoids to examine dosage and time of treatment as risk factors.
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The registration will take place at the study visit (approximately 90 minutes).
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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.
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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.
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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.
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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.
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Patients are genotyped for 4 polymorphisms (9 beta, ER22/23EK, Bcl1 and N363S) of the glucocorticoid receptor.
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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.
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Body composition
Time Frame: After the Synacthen® test the height, weight, waist and hip circumference are measured at the study visit.
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Height, weight, waist and hip circumference.
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After the Synacthen® test the height, weight, waist and hip circumference are measured at the study visit.
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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.
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Results from Dxa-scan.
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The results from latest Dxa-scan performed in rutine settings are collected from the patients on the same day as the Synacthen® test.
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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.
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Waistline, triglyceride level, HDL cholesterol level, blood pressure and fasting blood sugar is assessed in all the patients.
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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.
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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.
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Cortisol concentration in saliva.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulla Feldt-Rasmussen, Professor, Department of Endocrinology, Rigshospitalet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTx-CSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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