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Trial record 15 of 49 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT03191188
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Connie Rhee, University of California, Irvine

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Thyroid Disease Kidney Diseases, Chronic Drug: Levothyroxine Sodium Drug: Placebo Oral Tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Experimental: Levothyroxine Drug: Levothyroxine Sodium
Thyroid hormone supplement

Placebo Comparator: Placebo Drug: Placebo Oral Tablet
Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Health-related quality of life Short Form 36 questionnaire [ Time Frame: Baseline and 12 weeks ]
    Change in Short Form 36 score

  2. Serum Growth Differentiation Factor 15 (GDF15) level [ Time Frame: Baseline and 12 weeks ]
    Change in GDF15 level

  3. Serum soluble p-selectin level [ Time Frame: Baseline and 12 weeks ]
    Change in soluble p-selectin level

  4. Serum soluble CD40 ligand level [ Time Frame: Baseline and 12 weeks ]
    Change in serum soluble CD40 ligand level

  5. Body mass index [ Time Frame: Baseline and 12 weeks ]
    Change in body mass index

  6. Biceps skinfold [ Time Frame: Baseline and 12 weeks ]
    Change in biceps skinfold

  7. Triceps skinfold [ Time Frame: Baseline and 12 weeks ]
    Change in triceps skinfold

  8. Mid-arm circumference [ Time Frame: Baseline and 12 weeks ]
    Change in mid-arm circumference

  9. Mid-arm muscle circumference [ Time Frame: Baseline and 12 weeks ]
    Change in mid-arm muscle circumference

  10. Near infrared body fat percentage [ Time Frame: Baseline and 12 weeks ]
    Change in near infrared body fat percentage

  11. Subjective Global Assessment questionnaire [ Time Frame: Baseline and 12 weeks ]
    Subjective Global Assessment questionnaire score



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191188


Contacts
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Contact: Connie M. Rhee, MD, MSc 714-456-5142 crhee1@uci.edu

Locations
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United States, California
University Dialysis Center of Orange Recruiting
Orange, California, United States, 92868
Contact: Kamyar Kalantar-Zadeh, MD, MPH, PhD    714-634-3583    kkz@uci.edu   
Sponsors and Collaborators
University of California, Irvine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Connie M. Rhee, MD, MSc University of California, Irvine

Publications:
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Responsible Party: Connie Rhee, Assistant Professor of Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03191188     History of Changes
Other Study ID Numbers: HS#2014-1144
R03DK114642 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Thyroid Diseases
Urologic Diseases
Endocrine System Diseases
Renal Insufficiency
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs