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Spironolactone in CKD Enabled by Chlorthalidone: PILOT (SPICE PILOT)

Primary Purpose

Renal Insufficiency, Chronic Hypertension

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Chlorthalidone
Placebo
Sponsored by
Indiana Institute for Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency focused on measuring Spironolactone, Chlorthalidone, Chronic Kidney Disease, Hypertension, Thiazide Diuretic, Potassium Sparring Diuretic

Eligibility Criteria

19 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age greater than 18 years.
  2. GFR estimated by CKD-EPI formula < 45 ml/min/1.73 m2 but ≥ 15 mL/min/1.73 m2 using IDMS-calibrated creatinine.
  3. Hypertension. Using AOBP monitoring, BP of ≥ 130/80 mmHg.
  4. Treatment with antihypertensive drugs: This would require the use of at least one antihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or a beta-blocker at the time of randomization.
  5. Serum K 3.5 to 5.2 mEq/L at the time of randomization. In patients with eGFR < 45 ml/min/1.73 m2 and serum K > 5.2 mEq/L

Exclusion Criteria:

  1. Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-like drugs or the use of K supplements or K binders in the previous 12 weeks.
  2. Expected to receive renal replacement therapy within the next 6 months.
  3. Myocardial infarction, heart failure hospitalization, or stroke ≤ 12 weeks prior to randomization.
  4. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
  5. Known hypersensitivity to thiazide or spironolactone.
  6. Clinic AOBP <110 mmHg systolic at their first visit

Sites / Locations

  • Richard L Roudebush VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spironolactone + Placebo

Spironolactone + Chlorthalidone

Arm Description

Subjects with stage 3B/4 chronic kidney disease and poorly controlled hypertension will be randomized into two groups: one receiving spironolactone and placebo and one receiving spironolactone and chlorthalidone. At randomization, subjects will begin at 25 mg spironolactone and 6.25 mg placebo/chlorthalidone daily.

Subjects with stage 3B/4 chronic kidney disease and poorly controlled hypertension will be randomized into two groups: one receiving spironolactone and placebo and one receiving spironolactone and chlorthalidone. At randomization, subjects will begin at 25 mg spironolactone and 6.25 mg placebo/chlorthalidone daily.

Outcomes

Primary Outcome Measures

Change in Systolic Automated Office Blood Pressure from baseline to 12 weeks between arms

Secondary Outcome Measures

Change in logarithmically transformed albumin/creatinine ratio from baseline to 12 weeks between arms

Full Information

First Posted
January 18, 2022
Last Updated
August 11, 2023
Sponsor
Indiana Institute for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT05222191
Brief Title
Spironolactone in CKD Enabled by Chlorthalidone: PILOT
Acronym
SPICE PILOT
Official Title
Spironolactone in Chronic Kidney Disease Enabled by Chlorthalidone: A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana Institute for Medical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Highly prevalent among patients with chronic kidney disease (CKD) and poorly controlled blood pressure (BP), is a modifiable risk factor to abrogate both kidney failure progression and cardiovascular (CV) disease. Spironolactone (SPL), a mineralocorticoid receptor antagonist, is widely used to treat resistant hypertension, however one of the most common side effects is an increase of serum potassium (K). This side effect occurs frequently in those who suffer from CKD. Alternatively, chlorthalidone (CTD) is a thiazide-like diuretic used for treating hypertension and decreases serum K. In this pilot study, our goal is to assess whether the combination of SPL and CTD can improve BP control, while also reducing the risk of hyperkalemia over a period of 12 weeks. We hypothesize that among patients with CKD and poorly controlled hypertension, compared to SPL and placebo, treatment over 12 weeks with CTD will counter the hyperkalemia effect of SPL, and therefore the combination of SPL with CTD will result in a lower BP. This pilot study will be performed at Richard L. Roudebush VA in Indianapolis, Indiana.
Detailed Description
This is a placebo-controlled, double-blind, randomized controlled trial of spironolactone (SPL) and chlorthalidone (CTD) in patients with CKD and poorly controlled hypertension

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic Hypertension
Keywords
Spironolactone, Chlorthalidone, Chronic Kidney Disease, Hypertension, Thiazide Diuretic, Potassium Sparring Diuretic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone + Placebo
Arm Type
Active Comparator
Arm Description
Subjects with stage 3B/4 chronic kidney disease and poorly controlled hypertension will be randomized into two groups: one receiving spironolactone and placebo and one receiving spironolactone and chlorthalidone. At randomization, subjects will begin at 25 mg spironolactone and 6.25 mg placebo/chlorthalidone daily.
Arm Title
Spironolactone + Chlorthalidone
Arm Type
Experimental
Arm Description
Subjects with stage 3B/4 chronic kidney disease and poorly controlled hypertension will be randomized into two groups: one receiving spironolactone and placebo and one receiving spironolactone and chlorthalidone. At randomization, subjects will begin at 25 mg spironolactone and 6.25 mg placebo/chlorthalidone daily.
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
Study drugs will be increased if goal blood pressure is not achieved and/or serum potassium is not in safe clinical range (dosage of chlorthalidone/placebo not to exceed 25 mg daily; dosage of spironolactone not to exceed 50 mg daily).
Intervention Type
Drug
Intervention Name(s)
Chlorthalidone
Intervention Description
Study drugs will be increased if goal blood pressure is not achieved and/or serum potassium is not in safe clinical range (dosage of chlorthalidone/placebo not to exceed 25 mg daily; dosage of spironolactone not to exceed 50 mg daily).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Study drugs will be increased if goal blood pressure is not achieved and/or serum potassium is not in safe clinical range (dosage of chlorthalidone/placebo not to exceed 25 mg daily; dosage of spironolactone not to exceed 50 mg daily).
Primary Outcome Measure Information:
Title
Change in Systolic Automated Office Blood Pressure from baseline to 12 weeks between arms
Time Frame
Baseline to 12 Weeks
Secondary Outcome Measure Information:
Title
Change in logarithmically transformed albumin/creatinine ratio from baseline to 12 weeks between arms
Time Frame
Baseline to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years. GFR estimated by CKD-EPI formula < 45 ml/min/1.73 m2 but ≥ 15 mL/min/1.73 m2 using IDMS-calibrated creatinine. Hypertension. Using AOBP monitoring, BP of ≥ 130/80 mmHg. Treatment with antihypertensive drugs: This would require the use of at least one antihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or a beta-blocker at the time of randomization. Serum K 3.5 to 5.2 mEq/L at the time of randomization. In patients with eGFR < 45 ml/min/1.73 m2 and serum K > 5.2 mEq/L Exclusion Criteria: Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-like drugs or the use of K supplements or K binders in the previous 12 weeks. Expected to receive renal replacement therapy within the next 6 months. Myocardial infarction, heart failure hospitalization, or stroke ≤ 12 weeks prior to randomization. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable). Known hypersensitivity to thiazide or spironolactone. Clinic AOBP <110 mmHg systolic at their first visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajiv Agarwal, MD
Phone
317-988-2241
Email
ragarwal@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy l Ramsey, MS/MBA
Phone
317-988-9544
Email
timothy.ramsey2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Agarwal, MD
Organizational Affiliation
Indiana Institute for Medical Research; Roudebush VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy l ramsey, ms
Phone
317-988-9544
Email
timothy.ramsey2@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Spironolactone in CKD Enabled by Chlorthalidone: PILOT

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