search
Back to results

A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia (ADAPT)

Primary Purpose

Hyperkalemia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LOKELMA 5 GM Powder for Oral Suspension
Sponsored by
NephroNet, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperkalemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of informed consent prior to any study-specific procedures
  • Female or male aged above 18 years
  • Patients with ESRD receiving hemodialysis three times per week for a minimum of 3 months
  • Patients must have two (2) pre-dialysis K+ measurements between 5.1 and 6.5 mEq/L by Piccolo POCT following the long dialytic "weekends" (i.e., on two consecutive Mondays for patients on a Monday-Wednesday-Friday dialysis schedule or on two consecutive Tuesdays for patients on a Tuesday-Thursday-Saturday dialysis schedule) during screening, before insertion of the cardiac loop recorder.
  • Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) They should have been stable on their chosen method of birth control for a minimum of 1 month before entering the study and willing to remain on the birth control until 4 weeks after the last dose.

Exclusion Criteria:

-

Exclusion Criteria Related to the Underlying Condition:

  • Patients with a QTc(f) > 550 msec and/or Congenital long QT syndrome
  • Patients with a Haemoglobin < 9 g/dl.
  • Patients with any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation.
  • Patient receiving peritoneal or home hemodialysis
  • Patient receiving hemodialysis via a tunneled inferior vena cava (IVC) catheter and known central stenosis of access extremity
  • Patient receiving outpatient hemodialysis for < 3 months
  • Patient receiving outpatient hemodialysis for prolonged Acute Kidney Injury (AKI) and considered by the site Principal Investigator (PI) likely to achieve renal recovery within 6 months Note: Patients receiving out-patient hemodialysis for AKI for longer than 6 months with no demonstrable renal clearance can be screened for study participation.
  • Patient currently receiving a 1.0 K+, 3.0 K+ dialysate bath and unwilling to convert to a 2.0 K+/2.5 Ca++ dialysate bath
  • Subject unwilling to convert from a 2.0 K+ dialysate bath to a 3.0 K+ dialysate bath
  • Two or more pre-dialysis K+ of < 5.1 or > 6.5 mEq/L measured by Piccolo POCT after the long dialytic "weekends" during screening Note: If one of the two screening pre-dialysis K+ levels is between 4.6 to 5.0 mEq/L or 6.6 to 7.0 mEq/L, the patient can undergo an additional whole blood Piccolo POCT K+ measurement. Patients who fail the third whole blood Piccolo POCT K+ measurement will be considered ineligible for study participation. Note: Screen failures can be re-screened once to confirm eligibility in the study.
  • Any documented whole blood Piccolo POCT K+ measurement that falls below 4.6 mEq/L or exceeds 7.0 mEq/l during the screening period
  • Current use of a medication for treatment of hyperkalemia (e.g., Patiromer).
  • Note: If a medication for treatment of hyperkalemia is stopped prior to or after the consenting process, the subject will undergo a one week washout prior to the first whole blood Piccolo POCT K+ measurement. Exclusion Criteria Related to Other Medical Conditions and Treatments:
  • Anticipated life expectancy of 3 months duration
  • Development of atrial fibrillation requiring hospitalization, medical therapy, anticoagulation, or cardioversion during study pre-screening or screening period
  • Patient with a known placement of a dual or single chamber pacemaker
  • Patient with an automatic implantable cardiac defibrillator (AICD)
  • Patient with a LINQ implanted cardiac loop recorder with less than 6 months of battery life.
  • Current use of amiodarone or other anti-arrhythmic therapy. Note: Patients on such medications must undergo a two week washout prior to the first whole blood Piccolo POCT K+ measurement.
  • Known history of cardiac arrhythmias due to prolonged QT syndrome
  • Subject unwilling to receive an implanted LINQ cardiac loop recorder (unless 6 months are remaining in their previously implanted device).
  • Known active drug abuse
  • Positive hepatitis C polymerase chain reaction (PCR) test with active viral deoxyribonucleic acid (DNA) shedding or chronic active hepatitis B as evidenced by detectable surface antigen from standard of care routine dialysis labs. Note: Patients with negative PCR DNA testing for either hepatitis B or C will be allowed to participate in the study.
  • Known to have tested positive for human immunodeficiency virus (HIV) from standard of care routine dialysis labs.
  • For women only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
  • Patients with known and/or active severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders or diabetic gastroparesis Exclusion Criteria Related to the Investigational Product (IP):
  • Known hypersensitivity to sodium zirconium cyclosilicate (Lokelmaâ).

Other/General Exclusion Criteria:

  • Previous randomization in the present study. Note: Screen failures can be re-screened once to confirm eligibility in the study.
  • Participation in another interventional (non-observational) clinical study within 4 weeks prior to enrollment in the present study

Sites / Locations

  • Balboa ResearchRecruiting
  • Georgia Nephrology DBA Georgia Nephrology Research InstituteRecruiting
  • Nephrology Associates of Northern Illinois and Indiana (NANI)Recruiting
  • Clinical Research ConsultantsRecruiting
  • Mountain Kidney & Hypertension AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Rate Atrial fibrillation - 2.0K+ dialysate bath wo/ Lokelma to crossover

Rate Atrial fibrillation - 3.0K+ dialysate bath w/ 5 grams Lokelma to crossover

Arm Description

Sequence A: standard 2.0 K+/2.5 Ca++ dialysate with no Lokelma supplementation for two (2) months, followed by a cross-over to experimental 3.0 K+/2.5 Ca++ dialysate with 5 grams powder oral suspension Lokelma supplementation (on off-dialysis days) for two (2) months. Each two-month treatment period (both 2.0 K+/2.5 Ca++ dialysate and 3.0 K+/2.5 Ca++ dialysate with Lokelma sequences) will be preceded by a two-week run-in period, to allow the patient to adapt to the new dialysate bath. While receiving the higher K+ dialysate, patient will be treated on off-dialysis days (4 days/week) with Lokelma, titrated to maintain K+ between 4.0 and 5.5 mEq/L. Refer to section 7.2 for the initial dose and frequency details.

• Sequence B: experimental 3.0 K+/2.5 Ca++ dialysate with 5 grams Lokelma supplementation (on off-dialysis days) for two (2) months, followed by standard 2.0 K+/2.5 Ca++ dialysate with no Lokelma supplementation for two (2) months. Each two-month treatment period (both 2.0 K+/2.5 Ca++ dialysate and 3.0 K+/2.5 Ca++ dialysate with Lokelma sequences) will be preceded by a two-week run-in period, to allow the patient to adapt to the new dialysate bath. While receiving the higher K+ dialysate, patient will be treated on off-dialysis days (4 days/week) with Lokelma, titrated to maintain K+ between 4.0 and 5.5 mEq/L. Refer to section 7.2 for the initial dose and frequency details.

Outcomes

Primary Outcome Measures

The change in atrial Fibrillation events
To demonstrate whether increasing the K+ concentration in a standard hemodialysis bath from 2.0 K+ /2.5 Ca++ to a 3.0 K+ /2.5 Ca++ composition with SZC will reduce the incidence of atrial fibrillation events.

Secondary Outcome Measures

Frequency and duration of CSCAs (bradycardia, ventricular tachycardia and/or asystole)
To access whether the incidence and duration of post-dialysis CSCAs (defined as bradycardia, ventricular tachycardia and/or asystole) observed during experimental treatment will be reduced compared to standard treatment.
Whether or not K+ outside of the 4.0 to 5.5 mEq/L safety range (Yes/No binary outcome measure).
To determine whether the addition of oral sodium zirconium cyclosilicate (Lokelmaâ) during the 2-month treatment phase with the 3.0 K+ /2.5 Ca++ dialysate bath will reduce risk of weeks outside the "K+ safety range" of 4.0 to 5.5 mEq/L compared to the 2-month treatment phase with the 2.0 K+ /2.5 Ca++ dialysate bath.

Full Information

First Posted
August 23, 2022
Last Updated
October 27, 2022
Sponsor
NephroNet, Inc.
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT05535920
Brief Title
A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia
Acronym
ADAPT
Official Title
A Prospective, Randomized, Multi-Center, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia Following Augmentation of Dialysate Potassium
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NephroNet, Inc.
Collaborators
AstraZeneca

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
No

5. Study Description

Brief Summary
A Prospective, RanDomized, Multi-Center, Open-Label, Cross-Over Study of Sodium Zirconium Cyclosilicate to Control Interdialytic HyperkalemiA Following Augmentation of Dialysate Potassium: Efficacy to Reduce the Incidence of Post-Dialysis Atrial Fibrillation and Clinically SignificanT Cardiac Arrhythmias - ADAPT Trial
Detailed Description
This is a prospective, open-labelled, randomized, 2x2 cross-over design study of 88 patients with end stage renal disease (ESRD) receiving routine out-patient dialysis using a standard 2.0 potassium ion (K+)/2.5 calcium ion (Ca++) dialysate bath. The overall aim of the study is to determine whether converting stable hemodialysis patients from a "standard" 2.0 K+/2.5 Ca+ dialysate (without Lokelma) to a 3.0 K+/2.5 Ca++ mEq dialysate supplemented with the orally administered potassium binder sodium zirconium cyclosilicate (Lokelma) to treat interdialytic hyperkalemia will reduce the incidence and duration of post-dialysis atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Chronic outpatient hemodialysis patients have high rates of rapid changes in potassium and other electrolytes critical to the generation cardiac arrythmias. A growing body of data suggests that intra-dialytic K+ levels fall to level of 2.0 or lower and are a potential major contributor to the generation of atrial fibrillation, bradycardia, and other clinically significant arrhythmias. We propose that raising the dialysate bath to 3.0 K+ from current standard of care levels of 2.0 K+ will reduce levels of hypokalemia-induced arrhythmias. We further propose that the use of sodium zirconium cyclosilicate (Lokelma) will ensure that secondary hyperkalemia is controlled following the introduction of the 3.0 K+ dialysate bath.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rate Atrial fibrillation - 2.0K+ dialysate bath wo/ Lokelma to crossover
Arm Type
Other
Arm Description
Sequence A: standard 2.0 K+/2.5 Ca++ dialysate with no Lokelma supplementation for two (2) months, followed by a cross-over to experimental 3.0 K+/2.5 Ca++ dialysate with 5 grams powder oral suspension Lokelma supplementation (on off-dialysis days) for two (2) months. Each two-month treatment period (both 2.0 K+/2.5 Ca++ dialysate and 3.0 K+/2.5 Ca++ dialysate with Lokelma sequences) will be preceded by a two-week run-in period, to allow the patient to adapt to the new dialysate bath. While receiving the higher K+ dialysate, patient will be treated on off-dialysis days (4 days/week) with Lokelma, titrated to maintain K+ between 4.0 and 5.5 mEq/L. Refer to section 7.2 for the initial dose and frequency details.
Arm Title
Rate Atrial fibrillation - 3.0K+ dialysate bath w/ 5 grams Lokelma to crossover
Arm Type
Other
Arm Description
• Sequence B: experimental 3.0 K+/2.5 Ca++ dialysate with 5 grams Lokelma supplementation (on off-dialysis days) for two (2) months, followed by standard 2.0 K+/2.5 Ca++ dialysate with no Lokelma supplementation for two (2) months. Each two-month treatment period (both 2.0 K+/2.5 Ca++ dialysate and 3.0 K+/2.5 Ca++ dialysate with Lokelma sequences) will be preceded by a two-week run-in period, to allow the patient to adapt to the new dialysate bath. While receiving the higher K+ dialysate, patient will be treated on off-dialysis days (4 days/week) with Lokelma, titrated to maintain K+ between 4.0 and 5.5 mEq/L. Refer to section 7.2 for the initial dose and frequency details.
Intervention Type
Drug
Intervention Name(s)
LOKELMA 5 GM Powder for Oral Suspension
Intervention Description
Patients will use Lokelma supplementation on off-dialysis days (4 days/week) while receiving hemodialysis with 3.0 K+/2.5 Ca++ mEq dialysate bath. The individual starting dose will be 5.0 grams, and may be titrated weekly in 5.0 gram increments up to 15.0 grams to maintain K+ between 4.0 and 5.5 mEq/L.
Primary Outcome Measure Information:
Title
The change in atrial Fibrillation events
Description
To demonstrate whether increasing the K+ concentration in a standard hemodialysis bath from 2.0 K+ /2.5 Ca++ to a 3.0 K+ /2.5 Ca++ composition with SZC will reduce the incidence of atrial fibrillation events.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Secondary Outcome Measure Information:
Title
Frequency and duration of CSCAs (bradycardia, ventricular tachycardia and/or asystole)
Description
To access whether the incidence and duration of post-dialysis CSCAs (defined as bradycardia, ventricular tachycardia and/or asystole) observed during experimental treatment will be reduced compared to standard treatment.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Title
Whether or not K+ outside of the 4.0 to 5.5 mEq/L safety range (Yes/No binary outcome measure).
Description
To determine whether the addition of oral sodium zirconium cyclosilicate (Lokelmaâ) during the 2-month treatment phase with the 3.0 K+ /2.5 Ca++ dialysate bath will reduce risk of weeks outside the "K+ safety range" of 4.0 to 5.5 mEq/L compared to the 2-month treatment phase with the 2.0 K+ /2.5 Ca++ dialysate bath.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Other Pre-specified Outcome Measures:
Title
Total number of hypokalemic events defined as Piccolo POCT or laboratory-measured K+ of < 3.5 mEq/L.
Description
To evaluate whether the use of oral sodium zirconium cyclosilicate (Lokelmaâ) during periods when patients are receiving a 3.0 K+ /2.5 Ca++ dialysate bath is associated with hypokalemic events defined as K+ <3.5 mEq/L.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Title
Number of events (measured promptly prior to the termination of dialysis) where a Piccolo POCT measurement of K+ is < 3.5 mEq/L OR Ca++ is < 7.0 mEq/L, OR Mg++ is < 2.0 mg/dl, OR a PO4 level is <3.0 mEq/L
Description
To determine the levels of K+ , Mg++, calcium and PO4 during dialysis (measured promptly prior to the termination of dialysis) during experimental treatment compared to standard treatment.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Title
Frequencies of AEs, SAEs, and withdrawals due to AEs, with focus on treatment-related events.
Description
To evaluate the safety and tolerability of the experimental treatment compared to standard treatment based on the frequency of reported adverse experiences.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Title
Correlation between PBUTs (IS, PCS, and ADMA) and the frequency of atrial fibrillation events.
Description
To evaluate the relationship between proteinbound uremic toxins (PBUTs) and atrial fibrillation rates. PBUTs such indoxyl sulfate (IS) and p-Cresol. sulfate (PCS) can induce atrial fibrillation
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods
Title
Correlation between electrolyte levels and clinical events (intradialytic hypotension, muscle cramping, and cardiac events). Correlation between electrolytes falling below threshold levels
Description
To determine whether the levels of K+, Mg++, calcium and PO4 (measured promptly prior to the termination of dialysis) correlate with the incidence of clinical events, including intradialytic hypotension, muscle cramping, and cardiac events (defined as atrial fibrillation, bradycardia, ventricular tachycardia, and asystole). We will also evaluate whether the 3.0 K+ dialysate reduces the rates of these clinical events.
Time Frame
8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent prior to any study-specific procedures Female or male aged above 18 years Patients with ESRD receiving hemodialysis three times per week for a minimum of 3 months Patients must have two (2) pre-dialysis K+ measurements between 5.1 and 6.5 mEq/L by Piccolo POCT following the long dialytic "weekends" (i.e., on two consecutive Mondays for patients on a Monday-Wednesday-Friday dialysis schedule or on two consecutive Tuesdays for patients on a Tuesday-Thursday-Saturday dialysis schedule) during screening, before insertion of the cardiac loop recorder. Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) They should have been stable on their chosen method of birth control for a minimum of 1 month before entering the study and willing to remain on the birth control until 4 weeks after the last dose. Exclusion Criteria: - Exclusion Criteria Related to the Underlying Condition: Patients with a QTc(f) > 550 msec and/or Congenital long QT syndrome Patients with a Haemoglobin < 9 g/dl. Patients with any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation. Patient receiving peritoneal or home hemodialysis Patient receiving hemodialysis via a tunneled inferior vena cava (IVC) catheter and known central stenosis of access extremity Patient receiving outpatient hemodialysis for < 3 months Patient receiving outpatient hemodialysis for prolonged Acute Kidney Injury (AKI) and considered by the site Principal Investigator (PI) likely to achieve renal recovery within 6 months Note: Patients receiving out-patient hemodialysis for AKI for longer than 6 months with no demonstrable renal clearance can be screened for study participation. Patient currently receiving a 1.0 K+, 3.0 K+ dialysate bath and unwilling to convert to a 2.0 K+/2.5 Ca++ dialysate bath Subject unwilling to convert from a 2.0 K+ dialysate bath to a 3.0 K+ dialysate bath Two or more pre-dialysis K+ of < 5.1 or > 6.5 mEq/L measured by Piccolo POCT after the long dialytic "weekends" during screening Note: If one of the two screening pre-dialysis K+ levels is between 4.6 to 5.0 mEq/L or 6.6 to 7.0 mEq/L, the patient can undergo an additional whole blood Piccolo POCT K+ measurement. Patients who fail the third whole blood Piccolo POCT K+ measurement will be considered ineligible for study participation. Note: Screen failures can be re-screened once to confirm eligibility in the study. Any documented whole blood Piccolo POCT K+ measurement that falls below 4.6 mEq/L or exceeds 7.0 mEq/l during the screening period Current use of a medication for treatment of hyperkalemia (e.g., Patiromer). Note: If a medication for treatment of hyperkalemia is stopped prior to or after the consenting process, the subject will undergo a one week washout prior to the first whole blood Piccolo POCT K+ measurement. Exclusion Criteria Related to Other Medical Conditions and Treatments: Anticipated life expectancy of 3 months duration Development of atrial fibrillation requiring hospitalization, medical therapy, anticoagulation, or cardioversion during study pre-screening or screening period Patient with a known placement of a dual or single chamber pacemaker Patient with an automatic implantable cardiac defibrillator (AICD) Patient with a LINQ implanted cardiac loop recorder with less than 6 months of battery life. Current use of amiodarone or other anti-arrhythmic therapy. Note: Patients on such medications must undergo a two week washout prior to the first whole blood Piccolo POCT K+ measurement. Known history of cardiac arrhythmias due to prolonged QT syndrome Subject unwilling to receive an implanted LINQ cardiac loop recorder (unless 6 months are remaining in their previously implanted device). Known active drug abuse Positive hepatitis C polymerase chain reaction (PCR) test with active viral deoxyribonucleic acid (DNA) shedding or chronic active hepatitis B as evidenced by detectable surface antigen from standard of care routine dialysis labs. Note: Patients with negative PCR DNA testing for either hepatitis B or C will be allowed to participate in the study. Known to have tested positive for human immunodeficiency virus (HIV) from standard of care routine dialysis labs. For women only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding. Patients with known and/or active severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders or diabetic gastroparesis Exclusion Criteria Related to the Investigational Product (IP): Known hypersensitivity to sodium zirconium cyclosilicate (Lokelmaâ). Other/General Exclusion Criteria: Previous randomization in the present study. Note: Screen failures can be re-screened once to confirm eligibility in the study. Participation in another interventional (non-observational) clinical study within 4 weeks prior to enrollment in the present study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Whitson, BS
Phone
4239434265
Email
jwhitson@nephro-synergy.com
First Name & Middle Initial & Last Name or Official Title & Degree
Terry Smith
Phone
4239670917
Email
tsmith@nephronet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Tumlin, MD
Organizational Affiliation
NephroNet, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Whitson, BS
Organizational Affiliation
NephroNet, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Balboa Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DeShawn Roberson
Phone
619-461-3894
Email
droberson@balboaunited.org
First Name & Middle Initial & Last Name & Degree
Beatriz Alverez
Phone
6194613894
Email
Balvarez@balboaunited.org
First Name & Middle Initial & Last Name & Degree
Jill Meyer, MD
Facility Name
Georgia Nephrology DBA Georgia Nephrology Research Institute
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Whitson, BS
Phone
423-943-4265
Email
jwhitson@nephro-synergy.com
First Name & Middle Initial & Last Name & Degree
Angelica Blazan
Phone
4046457150
Email
abalzan@ganephrology.com
First Name & Middle Initial & Last Name & Degree
James A Tumlin, MD
Facility Name
Nephrology Associates of Northern Illinois and Indiana (NANI)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Valcarcel
Phone
260-494-3484
Email
KValcarcel@nephdocs.com
First Name & Middle Initial & Last Name & Degree
Nancy Cipparrone
Phone
2604943484
Email
ncipparrone@nephdocs.com
First Name & Middle Initial & Last Name & Degree
Andrew O-Shaughnessy, MD
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrahman Haroun
Phone
816-756-1222
Email
abdelrahman@crckcmo.com
First Name & Middle Initial & Last Name & Degree
Mary Parrigon
Phone
8167561222
Email
mary@crckcmo.com
First Name & Middle Initial & Last Name & Degree
Ahmed Awad, DO
Facility Name
Mountain Kidney & Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Evans
Phone
828-258-8545
Email
stephaniee@mtnkidney.com
First Name & Middle Initial & Last Name & Degree
Laurie Loudermilk
Phone
8282588545
Email
llowdermilk@mtnkidney.com
First Name & Middle Initial & Last Name & Degree
John Manley, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia

We'll reach out to this number within 24 hrs