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Trial record 14 of 20 for:    eplerenone | Recruiting, Not yet recruiting, Available Studies

Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT02525796
Recruitment Status : Recruiting
First Posted : August 17, 2015
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital

Brief Summary:
This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Drug: eplerenone Drug: amiloride Drug: Placebo Drug: Cinacalcet Phase 2 Phase 3

Detailed Description:

To conduct a double-blinded, placebo-controlled, randomized intervention study to investigate whether mineralocorticoid receptor (MR) antagonism, alone or in combination with cinacalcet, is an effective therapy for primary hyperparathyroidism (P-HPTH).

Hypothesis: MR antagonism, as a monotherapy or in combination with a calcimimetic, is a mechanism to lower parathyroid hormone (PTH) in primary hyperparathyroidism (P-HPTH).

Study Design: Sixty subjects with P-HPTH will be enrolled to randomly receive eplerenone (a potassium-sparing diuretic that directly blocks the MR), amiloride (a potassium-sparing diuretic that does not directly block the MR), or placebo for 4 weeks. Thereafter, all subjects will receive cinacalcet therapy (a calcimimetic that lowers PTH) in addition to their randomized intervention for an additional 2 weeks.

Anticipated Results: In this proof-of-concept study, eplerenone therapy will lower PTH, serum calcium, and markers of bone resorption in P-HPTH, when compared to placebo. The PTH response to amiloride will resemble that of placebo, suggesting that the eplerenone mediated reductions in PTH are specific to interactions with the MR. Combination therapy with eplerenone + cinacalcet will result in additive or synergistic reductions in PTH, when compared to placebo + cinacalcet or placebo + amiloride.

Implications: MR antagonism (alone or in combination with cinacalcet) may be a mechanism to lower PTH and calcium in P-HPTH, thereby identifying a new potential option in the limited medical therapies for P-HPTH.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Placebo Comparator: Placebo + Cinacalcet
Patients with primary hyperparathyroidism will receive placebo for 4 weeks followed by the addition of cinacalcet for 2 weeks
Drug: Placebo Drug: Cinacalcet
Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID
Active Comparator: Amiloride + Cinacalcet
Patients with primary hyperparathyroidism will receive amiloride for 4 weeks followed by the addition of cinacalcet for 2 weeks
Drug: amiloride
amiloride, titrated up to a maximum of 10mg BID
Drug: Cinacalcet
Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID
Experimental: Eplerenone + Cinacalcet
Patients with primary hyperparathyroidism will receive eplerenone for 4 weeks followed by the addition of cinacalcet for 2 weeks
Drug: eplerenone
eplerenone, titrated up to a maximum of 50mg BID
Drug: Cinacalcet
Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID



Primary Outcome Measures :
  1. Change in parathyroid hormone levels [ Time Frame: 4 weeks ]
    Change in circulating PTH levels before and after intervention when compared to placebo


Secondary Outcome Measures :
  1. Change in calcium levels [ Time Frame: 4 weeks ]
    Change in serum calcium levels before and after intervention when compared to placebo



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • physician diagnosis of active P-HPTH (Serum calcium > upper limit of reference range and serum PTH > ULRR; or Serum Calcium > ULRR AND serum PTH > 30 pg/mL; or Serum Calcium within 0.2 mg/dL of the ULRR and PTH>ULRR).
  • negative pregnancy test in women aged 18-45

Exclusion Criteria:

  • estimated glomerular filtration rate < 60mL/min/1,73m2
  • serum potassium > 5.0 mmol/L
  • age <18 or >80 years
  • diabetes that is not well controlled (HbA1c>8%)\
  • liver failure
  • heart failure
  • history of myocardial infarction or stroke
  • active use of lithium
  • active chronic inflammatory conditions (such as inflammatory bowel disease, rheumatoid arthritis, sarcoidosis)
  • initiation within 3 months of bisphosphonates or cinacalcet
  • need for imminent parathyroidectomy (within the next 6-8 weeks) as determined by their endocrinologist or surgeon
  • absolute serum calcium >13.0 mg/dL
  • positive pregnancy test on any of the study visits for women ages 18-45.

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): NCT02525796


Contacts
Contact: Anand Vaidya, MD MMSc 617-525-8285
Contact: Molly Connors 617-732-5186

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Molly Connors    617-732-5186      
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Anand Vaidya, MD MMSc Brigham and Women's Hospital, Harvard Medical School

Responsible Party: Anand Vaidya, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02525796     History of Changes
Other Study ID Numbers: 107407
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with interested investigators upon request 1 year after the study is completed. Investigators may request IPD by contacting the PI and proposing a data analysis plan

Additional relevant MeSH terms:
Eplerenone
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Spironolactone
Amiloride
Cinacalcet Hydrochloride
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Calcimimetic Agents
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers