An Effectiveness-Implementation Trial of SPIRIT in ESRD

April 15, 2026 updated by: Mi-Kyung Song, Emory University

Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by patients and their surrogates with sufficient time to consider alternatives such as hospice or dying at home. Over the last decade, the researchers have developed and iteratively tested a patient and family-centered advance care planning intervention based on the Representational Approach to Patient Education called "Sharing Patient's Illness Representation to Increase Trust" (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates.

This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. The researchers will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from dialysis clinics in four states. Patients and surrogates will complete questionnaires at baseline and two weeks after the intervention. Surrogates will complete a post-bereavement assessment three months after the death of the patient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

End-stage renal disease (ESRD) currently affects nearly 662,000 people in the U.S. While dialysis is the treatment of choice for over 90% of patients with ESRD and is universally covered by Medicare regardless of patient age or means, the likelihood that dialysis can restore health or prolong life is limited; only 50% of dialysis patients are alive 3 years after the onset of ESRD. Thus many dialysis patients and their family members or surrogate decision-makers have to face difficult end-of-life decisions. Although advance care planning (ACP), in which patients and surrogate decision-makers discuss future health states and treatment options, is a central tenet of dialysis care, the vast majority of dialysis patients (>90%) report never engaging in ACP discussions with their care providers. The lack of effective ACP to prepare patients and their surrogates for end-of-life decision making with sufficient time before death has deleterious consequences at all levels of society. Consequences have been well documented: prolonged use of futile treatment at the end of life, which misuses the healthcare system, high levels of surrogate distress during decision making, which emanates from not having a clear understanding of the patient's wishes, and surrogates experiencing later sequelae of psychosocial morbidities, such as depression and family discord.

"Sharing Patient's Illness Representation to Increase Trust" (SPIRIT), a patient and family-centered ACP intervention based on the Representational Approach to Patient Education, was designed by the research team to establish a testable model of how end-of-life care discussions could occur between a dialysis patient and his/her chosen surrogate (usually a spouse or adult child). The discussions, which are facilitated by a trained care provider, are framed around addressing each individual's representations of (beliefs about) the illness and views of life-sustaining measures at the end of life. SPIRIT follows a six-step learning objective over two-sessions, which together take about 60 minutes. The care provider, who is value-neutral, guides the patient in examining his/her values related to end-of-life care, helps the surrogate understand the patient's illness progression, and prepares the surrogate for his/her role as a surrogate in a highly emotionally charged medical setting. Over the last decade, SPIRIT has been tested to establish feasibility, patient-surrogate acceptability, and efficacy. In these explanatory trials carried out in dialysis clinics, SPIRIT was delivered by trained research nurses. Patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, including the extent to which: a) the patient and surrogate agreed on end-of-life care goals, b) the patient had reduced conflict about the benefits and burdens of life-sustaining treatments, and c) the surrogate had increased confidence about the role of surrogate. Key to establishing the utility of this approach for broader generalizability, surrogates who received SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to those who did not. The logical, critical next step is to ask: Will SPIRIT be effective as part of routine care in real-world clinical settings with less control? To address this very issue, the researchers will conduct a real-world effectiveness-implementation study, an essential step prior to widespread implementation of SPIRIT.

This study is a multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics compared to usual care plus delayed SPIRIT implementation. Simultaneously, the researchers will evaluate the implementation of SPIRIT, including sustainability. This study will use a Type I effectiveness-implementation hybrid approach that combines testing intervention effectiveness and gathering information about implementation of an efficacious intervention in a real world setting. To maximize data on the implementation process and sustainability, the researchers chose a delayed intervention design in which clinics are randomized either to implement SPIRIT immediately after randomization (i.e., initial implementation) or to maintain usual care for a comparison condition and then implement the intervention in control clinics following conclusion of this clinical trial (i.e., delayed implementation). The intent of the delayed implementation group was provide descriptive data for translation of the intervention into clinical practice (versus data collected on dyad participants in this current study), however, this portion of the study could not be performed due to the coronavirus disease 2019 (COVID-19) pandemic.

The short-term goal is to generate sufficient evidence to accelerate the integration of SPIRIT into dialysis practice and policy. This study will recruit 400 dyads of patients at high risk of death in the next year and their surrogates (a total of 800 individuals) from dialysis clinics in four states. The dialysis clinics will be randomized to implement SPIRIT or to maintain usual care to serve as a control to the intervention. Participants will complete a follow-up assessment two weeks after the the study intervention. They will then be observed for 9 months (or until the death of the patient) with an optional extension of the observational period for an additional 12 months, for up to 21 months of observation. Individual patient participation will end after the observation period (9 or 21 months) or death, whichever occurs first; surrogate participation will end after the observation period (9 or 21 months) or at the completion of the post-bereavement surveys which are administered 3-months after the death of the patient (up to 24 months).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
852

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Emory Dialysis at Northside
      • Atlanta, Georgia, United States, 30331
        • Emory Dialysis at Greenbriar
      • Decatur, Georgia, United States, 30034
        • Emory Dialysis at Candler
      • North Decatur, Georgia, United States, 30033
        • Emory Dialysis Center
    • New Mexico
      • Acoma Pueblo, New Mexico, United States, 87034
        • Dialysis Clinic, Inc - Acoma Canoncito Laguna
      • Albuquerque, New Mexico, United States, 87102
        • Dialysis Clinic, Inc - Albuquerque
      • Albuquerque, New Mexico, United States, 87105
        • Dialysis Clinic, Inc - Albuquerque South
      • Albuquerque, New Mexico, United States, 87110
        • Dialysis Clinic, Inc - Albuquerque East
      • Carlsbad, New Mexico, United States, 88220
        • Dialysis Clinic, Inc - Carlsbad
      • Cuba, New Mexico, United States, 87013
        • Dialysis Clinic, Inc - Cuba
      • Grants, New Mexico, United States, 87020
        • Dialysis Clinic, Inc - Grants
      • Raton, New Mexico, United States, 87740
        • Dialysis Clinic, Inc - Raton
      • Rio Rancho, New Mexico, United States, 87124
        • Dialysis Clinic, Inc - Rio Rancho
      • Santo Domingo Pueblo, New Mexico, United States, 87052
        • Dialysis Clinic, Inc - Santo Domingo
      • Silver City, New Mexico, United States, 88061
        • Dialysis Clinic, Inc - Silver City
      • Taos, New Mexico, United States, 87571
        • Dialysis Clinic, Inc - Taos
    • North Carolina
      • Carrboro, North Carolina, United States, 27510
        • Carolina Dialysis - Carrboro
      • Mebane, North Carolina, United States, 27302
        • Carolina Dialysis - Mebane
      • Pittsboro, North Carolina, United States, 27312
        • Carolina Dialysis - Pittsboro
      • Raleigh, North Carolina, United States, 27610
        • Fresenius Kidney Care - Raleigh
      • Sanford, North Carolina, United States, 27332
        • Carolina Dialysis-Sanford Lee County
      • Sanford, North Carolina, United States, 27332
        • Carolina Dialysis-Sanford Main
      • Siler City, North Carolina, United States, 27344
        • Carolina Dialysis - Siler City
    • Pennsylvania
      • Cheswick, Pennsylvania, United States, 15024
        • Dialysis Clinic, Inc - Harmar Village
      • Monroeville, Pennsylvania, United States, 15146
        • Dialysis Clinic, Inc - Monroeville/Five Points
      • North Versailles, Pennsylvania, United States, 15137
        • Dialysis Clinic, Inc - North Versailles
      • Pittsburgh, Pennsylvania, United States, 15213
        • Dialysis Clinic, Inc - Oakland
      • Pittsburgh, Pennsylvania, United States, 15216
        • Dialysis Clinic, Inc - Banksville
      • Pittsburgh, Pennsylvania, United States, 15221
        • Dialysis Clinic, Inc - Wilkinsburg
      • Pittsburgh, Pennsylvania, United States, 15237
        • Dialysis Clinic, Inc - North Hills
    • Virginia
      • Altavista, Virginia, United States, 24517
        • UVA Dialysis Altavista Clinic
      • Amherst, Virginia, United States, 24521
        • UVA Dialysis Amherst Clinic
      • Charlottesville, Virginia, United States, 22903
        • Kidney Center Outpatient Dialysis Clinic
      • Farmville, Virginia, United States, 23901
        • UVA Dialysis Clinic Farmville
      • Fishersville, Virginia, United States, 22939
        • UVA Augusta Dialysis
      • Gordonsville, Virginia, United States, 22942
        • UVA Dialysis Zion Crossroads
      • Lynchburg, Virginia, United States, 24501
        • UVA Dialysis Lynchburg
      • Orange, Virginia, United States, 22960
        • UVA Dialysis Orange Clinic
      • Staunton, Virginia, United States, 24401
        • UVA Dialysis Clinic Staunton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Patients:

  • on either hemodialysis or peritoneal dialysis
  • able to understand and speak English

Exclusion Criteria for Patients:

  • lack of an available surrogate
  • too ill or cognitively impaired to participate based on clinicians' judgment
  • already enrolled in hospice

Inclusion Criteria for Surrogates:

  • are chosen as a surrogate by the patient
  • paid caregivers who will not be participating in medical decisions for the patient

Exclusion Criteria for Surrogates:

  • Unable to complete questionnaires due to physical or cognitive limitations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SPIRIT Clinic
Patients at clinics that have been randomized to the SPIRIT arm will be given the option to participate in the intervention. SPIRIT is a two-session, 60-minute, structured psychoeducational intervention, targeting both patient and surrogate. Using a provider manual, the care provider follows six steps: 1) assessing illness presentation, 2) identifying gaps and concerns, 3) creating conditions for conceptual change, 4) introducing replacement information, 5) summarizing, and 6) setting goals and planning.
Behavioral: SPIRIT

SPIRIT is a two-session, structured psychoeducational intervention assisting patients clarify their end-of-life preferences and helping surrogates understand the patient's wishes and prepare for the surrogate role.

During the first session (about 45 minutes) individualized information is provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the care provider will assist the patient to examine his/her values about life-sustaining treatment. The surrogate will receive help preparing for end-of-life decision-making and the emotional burden of decision-making. A Goals-of-Care document will be completed to indicate the patient's preferences.

Two weeks later, the second session (about 15 minutes) addresses remaining or new concerns. The patient's Goals-of-Care document will be reviewed. The patient's end-of-life preferences and surrogate's name and relationship to the patient will be documented in the medical record.

Other Names:
  • Sharing Patient's Illness Representation to Increase Trust
Active Comparator: Comparison Condition Clinic
Patients at clinics that have been randomized to the control arm will be given the option to participate as a study control. The control clinics will have delayed implementation of the SPIRIT intervention.
Behavioral: Comparison Condition
As required by Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an AD. This typically takes about 10 minutes.
Other Names:
  • Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dyad Congruence on Goals-of-Care Tool
Time Frame: Baseline, Week 2
The Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in end-stage renal disease (ESRD) patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are compared to determine dyad congruence. A dyad is assigned with "1" if each member of the dyad chose the same response (either comfort care only or continue aggressive care) in both scenarios. In all other cases, the dyad is assigned with "0", which includes: 1) the patient and surrogate responses are the same in one of the two scenarios, 2) the patient and surrogate responses differ in both scenarios, and 3) the patient and surrogate responses are both "I am not sure".
Baseline, Week 2
Patient's Decisional Conflict Scale (DCS) Score
Time Frame: Baseline, Week 2
Patient decisional conflict is measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 to 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.
Baseline, Week 2
Surrogate's Decision Making Confidence (DMC) Scale Score
Time Frame: Baseline, Week 2
Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (4) "Very confident". Total scores range from 0 to 20, with higher scores indicating greater confidence.
Baseline, Week 2
Composite Outcome of Dyad Congruence and Surrogate DMC Score
Time Frame: Baseline, Week 2
The composite outcome combines dyad congruence on Goals-of-Care scenarios and surrogate DMC scores. If the dyad congruence is 1 and the surrogate's DMC >=3, then the composite outcome value for the dyad is "1". In all other cases, the dyad's composite outcome value is "0".
Baseline, Week 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surrogate's Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Time Frame: Baseline, 3 months after patient death (up to 24 months)
Surrogate post-bereavement anxiety symptoms were measured with the Hospital Anxiety and Depression Scale (HADS) Anxiety subscale. Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). Scores for the anxiety subscale range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety.
Baseline, 3 months after patient death (up to 24 months)
Surrogate's Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Time Frame: Baseline, 3 months after patient death (up to 24 months)
Surrogate post-bereavement symptoms of depression were measured with the Hospital Anxiety and Depression Scale (HADS) Depression subscale. Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). Total scores of the depression subscale range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of depression.
Baseline, 3 months after patient death (up to 24 months)
Surrogate's Post-Traumatic Symptoms Scale-10 (PTSS-10) Score
Time Frame: Baseline, 3 months after patient death (up to 24 months)
Surrogate post-bereavement traumatic distress was measured with the Post-Traumatic Symptoms Scale-10 (PTSS-10). Surrogates indicate how often they have experienced symptoms of post-traumatic stress by responding to 10 symptoms on a scale of 1 to 7 where 1 = "never" and 7 = "always". Total scale scores range from 10 to 70 and higher scores indicate more intense symptoms.
Baseline, 3 months after patient death (up to 24 months)
End-of-life Treatment Intensity Among Participants With Medicare
Time Frame: Upon patient death (up to 21 months)
The use of intensive procedures during end-of-life treatment is identified through the United States Renal Data System (USRDS). Among participants having Medicare, admission to hospice, withdrawal of dialysis, and institutional death were documented.
Upon patient death (up to 21 months)
End-of-life Treatment Intensity Among Participants With Medicare as the Primary Payer
Time Frame: Upon patient death (up to 21 months)
The use of intensive procedures during end-of-life treatment is identified through the United States Renal Data System (USRDS). Among participants having Medicare as the primary payer, admission to the hospital, intensive care unit, or a skilled nursing facility was documented, as well as intensive procedures of cardiopulmonary resuscitation (CPR), intubation, mechanical ventilation, and feeding (gastronomy or jejunal) tube insertion.
Upon patient death (up to 21 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mi-Kyung Song, PhD, RN, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00094859
  • 1R01NR017018-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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