Thyroid DiseaseNCT03191188
A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
A study testing Levothyroxine Sodium in people with Thyroid Disease and Kidney Diseases, Chronic, run by University of California, Irvine at 1 site in United States.
Trial summary
Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Disease, Kidney Diseases, Chronic
- What is being tested?
- Levothyroxine Sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to Jul 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.
Who cannot join
- Hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Dialysis Center of Orange
Orange, California, 92868
Kamyar Kalantar-Zadeh, MD, MPH, PhD, 714-634-3583, kkz@uci.edu
About this study
Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. While levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. This study will investigate 1) whether levothyroxine adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.
- Conditions
- Thyroid Disease, Kidney Diseases, Chronic
- Being tested
- Levothyroxine Sodium, Placebo Oral Tablet
- Medical subject headings
- Thyroid Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine SodiumDrug
Thyroid hormone supplement
Placebo Oral TabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | Not described Receives: Drug: Levothyroxine Sodium |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L
Number of patients achieving target TSH levels of 0.5-3.0mIU/L
Measured: 12 weeks
Secondary outcomes (11)
Health-related quality of life Short Form 36 questionnaire
Change in Short Form 36 score
Measured: Baseline and 12 weeks
Serum Growth Differentiation Factor 15 (GDF15) level
Change in GDF15 level
Measured: Baseline and 12 weeks
Serum soluble p-selectin level
Change in soluble p-selectin level
Measured: Baseline and 12 weeks
Serum soluble CD40 ligand level
Change in serum soluble CD40 ligand level
Measured: Baseline and 12 weeks
Body mass index
Change in body mass index
Measured: Baseline and 12 weeks
Biceps skinfold
Change in biceps skinfold
Measured: Baseline and 12 weeks
Triceps skinfold
Change in triceps skinfold
Measured: Baseline and 12 weeks
Mid-arm circumference
Change in mid-arm circumference
Measured: Baseline and 12 weeks
Mid-arm muscle circumference
Change in mid-arm muscle circumference
Measured: Baseline and 12 weeks
Near infrared body fat percentage
Change in near infrared body fat percentage
Measured: Baseline and 12 weeks
Subjective Global Assessment questionnaire
Subjective Global Assessment questionnaire score
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jul 2017
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Connie M. Rhee, MD, MSc, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191188
- Sponsor's protocol ID
- HS#2014-1144
- Other IDs
- R03DK114642
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2017
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
PubMed 28324018Rhee CM, Kim S, Gillen DL, Oztan T, Wang J, Mehrotra R, Kuttykrishnan S, Nguyen DV, Brunelli SM, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Association of thyroid functional disease with mortality in a national cohort of incident hemodialysis patients. J Clin Endocrinol Metab. 2015 Apr;100(4):1386-95. doi: 10.1210/jc.2014-4311. Epub 2015 Jan 29.
PubMed 25632971Rhee CM, Ravel VA, Streja E, Mehrotra R, Kim S, Wang J, Nguyen DV, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort. J Clin Endocrinol Metab. 2016 Nov;101(11):4054-4061. doi: 10.1210/jc.2016-1691. Epub 2016 Aug 15.
PubMed 27525529Rhee CM, Kalantar-Zadeh K, Streja E, Carrero JJ, Ma JZ, Lu JL, Kovesdy CP. The relationship between thyroid function and estimated glomerular filtration rate in patients with chronic kidney disease. Nephrol Dial Transplant. 2015 Feb;30(2):282-7. doi: 10.1093/ndt/gfu303. Epub 2014 Sep 21.
PubMed 25246335
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
- ClinicalTrials.gov ID
- NCT03191188
- Acronym / sponsor ID
- HS#2014-1144
- Conditions
- Thyroid Disease, Kidney Diseases, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 19 Jun 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.
Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. While levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. This study will investigate 1) whether levothyroxine adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: Levothyroxine Sodium |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.
Key exclusion criteria (1 listed)
- Hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.
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 |
|---|---|---|
| Levothyroxine SodiumThyroid hormone supplement | Drug | Levothyroxine |
| Placebo Oral TabletPlacebo | Drug | Placebo |
Primary outcome
Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L
Time frame: 12 weeks
Number of patients achieving target TSH levels of 0.5-3.0mIU/L
11 secondary outcomes
Health-related quality of life Short Form 36 questionnaire
Time frame: Baseline and 12 weeks
Serum Growth Differentiation Factor 15 (GDF15) level
Time frame: Baseline and 12 weeks
Serum soluble p-selectin level
Time frame: Baseline and 12 weeks
Serum soluble CD40 ligand level
Time frame: Baseline and 12 weeks
Body mass index
Time frame: Baseline and 12 weeks
Biceps skinfold
Time frame: Baseline and 12 weeks
Triceps skinfold
Time frame: Baseline and 12 weeks
Mid-arm circumference
Time frame: Baseline and 12 weeks
Mid-arm muscle circumference
Time frame: Baseline and 12 weeks
Near infrared body fat percentage
Time frame: Baseline and 12 weeks
Subjective Global Assessment questionnaire
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Background: PubMed 28324018Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
- Background: PubMed 25632971Rhee CM, Kim S, Gillen DL, Oztan T, Wang J, Mehrotra R, Kuttykrishnan S, Nguyen DV, Brunelli SM, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Association of thyroid functional disease with mortality in a national cohort of incident hemodialysis patients. J Clin Endocrinol Metab. 2015 Apr;100(4):1386-95. doi: 10.1210/jc.2014-4311. Epub 2015 Jan 29.
- Background: PubMed 27525529Rhee CM, Ravel VA, Streja E, Mehrotra R, Kim S, Wang J, Nguyen DV, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort. J Clin Endocrinol Metab. 2016 Nov;101(11):4054-4061. doi: 10.1210/jc.2016-1691. Epub 2016 Aug 15.
- Background: PubMed 25246335Rhee CM, Kalantar-Zadeh K, Streja E, Carrero JJ, Ma JZ, Lu JL, Kovesdy CP. The relationship between thyroid function and estimated glomerular filtration rate in patients with chronic kidney disease. Nephrol Dial Transplant. 2015 Feb;30(2):282-7. doi: 10.1093/ndt/gfu303. Epub 2014 Sep 21.
- Individual participant dataSharing planned: No
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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.
Connie M. Rhee, MD, MSc principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine Sodium in people with Thyroid Disease and Kidney Diseases, Chronic, run by University of California, Irvine 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?
The sponsor lists 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Connie M. Rhee, MD, MSc (714-456-5142, crhee1@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L (time frame: 12 weeks). 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 NCT03191188, which also lists 4 linked publications.
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 14 Jun 2021.