NCT05222191 (SPICE PILOT) is a Phase 2 clinical trial of Spironolactone in Renal Insufficiency, sponsored by Indiana Institute for Medical Research.

Who is sponsoring NCT05222191?

NCT05222191 is sponsored by Indiana Institute for Medical Research.

What drugs are being tested in NCT05222191?

Interventions in NCT05222191: Spironolactone, Chlorthalidone, Placebo.

What condition does NCT05222191 study?

NCT05222191 studies Renal Insufficiency, Chronic Hypertension.

Is NCT05222191 still recruiting?

NCT05222191 is currently status unknown. Last updated 14 August 2023.

Last reviewed 2023-08-14 · How we verify

NCT05222191: SPICE PILOT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Status unknown Phase 2 Last updated 14 August 2023

What this trial tests

Phase 2 trial testing Spironolactone in Renal Insufficiency in 24 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
12 December 2023

12 December 2023

Quick facts

Lead sponsor	Indiana Institute for Medical Research
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	1 February 2022
Primary completion	12 December 2023
Estimated completion	12 December 2023
Sites	1 location across United States

Drugs / interventions tested

Spironolactone (spironolactone) — full drug profile →
Chlorthalidone — full drug profile →
Placebo

Conditions studied

Renal Insufficiency — all drugs for Renal Insufficiency →
Chronic Hypertension — all drugs for Chronic Hypertension →

Sponsor

Indiana Institute for Medical Research

Who can join

Adults 19 to 110, any sex, with Renal Insufficiency or Chronic Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Spironolactone

Trials testing the same drug.

NCT07020104 — The Role of Skin Sodium Accumulation in Chronic Kidney Disease · NA · recruiting
NCT06204640 — SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation · Phase 3 · not yet recruiting
NCT06164379 — Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism · Phase 4 · unknown
NCT06004830 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1 · Phase 2 · active not recruiting
NCT06641284 — Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone · completed

Other recruiting trials for Renal Insufficiency

Currently open trials in the same condition.

NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT07001436 — A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insuffici · Phase 1 · recruiting
NCT06431789 — Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in P · recruiting
NCT06354231 — DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC · Phase 2 · recruiting
NCT05428631 — Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Ca · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05222191 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana Institute for Medical Research
Last refreshed: 14 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05222191.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing