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Trial record 3 of 3 for:    SLC12A3

Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus (TT)

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ClinicalTrials.gov Identifier: NCT02644395
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ewout Hoorn, Erasmus Medical Center

Brief Summary:

Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs to prevent rejection after kidney transplantation. However, the efficacy of preventing rejection comes at the cost of important side-effects. Among the most common side-effects is hypertension. Hypertension after kidney transplantation is clinically relevant, because it increases the risk of cardiovascular disease and is associated with increased graft loss and recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood and, therefore, the treatment is currently empiric. These and other investigators recently showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the kidney, namely the thiazide-sensitive sodium chloride cotransporter.

Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to calcium channel blockers (CCBs) (currently usually the treatment of choice) for the treatment of CNI-induced hypertension.

Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients with CNI-induced hypertension.

Study design: Single-center, randomized cross-over trial.

Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30 ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not have proteinuria (< 1 g/day).

Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10 mg once daily).

Main study parameters/endpoints: 24-hour blood pressure recording.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both drugs have long been registered for the treatment of hypertension. The side-effect profile of both drugs is considered to be equal. The burden of the study for the patients are blood pressure measurements using 30-minute automated blood pressure measurement and 24-hour ambulatory blood pressure measurement.


Condition or disease Intervention/treatment Phase
Hypertension Kidney Transplantation Drug: Chlorthalidone Drug: Amlodipine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus
Actual Study Start Date : January 18, 2013
Actual Primary Completion Date : December 17, 2015
Actual Study Completion Date : December 19, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Amlodipine
Current treatment of choice
Drug: Amlodipine
Drug

Experimental: Chlorthalidone
Testing new indication for approved drug
Drug: Chlorthalidone
Drug




Primary Outcome Measures :
  1. Average daytime SBP [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Laboratory parameters [ Time Frame: 8 weeks ]
  2. Side effects [ Time Frame: 8 weeks ]


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

Inclusion Criteria:

  • Kidney transplant recipients using tacrolimus
  • Average daytime SBP > 140 mm Hg (ABPM)
  • eGFR > 30 ml/min (MDRD)

Exclusion Criteria:

  • Use of glucocorticoids, co-trimoxazole, diuretics
  • Pregnancy
  • Serum sodium < 136, serum potassium < 3.5
  • Proteinuria > 1 g/day

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): NCT02644395


Locations
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Netherlands
ErasmusMC
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center

Publications:
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Responsible Party: Ewout Hoorn, Associate Professor, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02644395     History of Changes
Other Study ID Numbers: MEC-2012-417
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Tacrolimus
Amlodipine
Chlorthalidone
Diuretics
Sodium Chloride Symporter Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Natriuretic Agents