An interventional study of Technology Assisted Stepped Collaborative Care and Usual Care Arm in Chronic Kidney Disease Requiring Hemodialysis, sponsored by University of Pittsburgh. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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Among 988 studies in Renal Insufficiency, Chronic with a site in United States — 171 open to participants now, 218 under way, 25 of them phase 3. Renal Insufficiency, Chronic · United States.
Among the 988 studies in Renal Insufficiency, Chronic with a site in United States, this one is the 123rd largest by planned enrollment of the 819 interventional ones that give a count, is one of 57 that started in 2025, is one of 314 with no phase, reaches primary completion later than 173 of the 216 other live ones, and was the 906th registered.
3,094 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →171 of the 988 studies in Renal Insufficiency, Chronic with a site in United States are open now. Recruiting first, the newest first:
University of Chicago · Sites in United States
Ages 18–70
Indiana University · Sites in United States
Ages 40–70
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
University of Minnesota · Sites in United States
Ages 30–75
United Therapeutics · Sites in United States
Ages 40–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 434 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
988 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 109 · Phase 2 185 · Phase 3 160 · Phase 4 81
First in 1988; this study’s year is marked. 57 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 424 is above the median of 73 across 2,161 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 72 across the 819 interventional studies, 125 across the 165 observational. Of the 696 that completed or were terminated, 344 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
372 of 988 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,420 studies on the registry; 169 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 7 studies filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
73 of the studies in Renal Insufficiency, Chronic with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03565913Phase 3University of Texas Southwestern Medical CenterPotential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V | 2026-12-01 |
| NCT06531824Phase 3Boehringer IngelheimEASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | 2026-12-31 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT07107945Phase 3Boehringer IngelheimA Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) | 2027-04-16 |
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
Add all 73 to your calendar (.ics) → With an account.
Among the 988 studies in Renal Insufficiency, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.
The goal of this study is to conduct a hybrid Type II effectiveness-implementation, cluster randomized trial of TĀCcare 2.0 facilitated by dialysis staff in a real-world setting. This is a multi-center, dialysis-clinic level cluster randomized trial of 424 patients from 36 dialysis clinics comparing TACcare 2.0 facilitated by dialysis staff versus usual care. Patients' dialysis clinic will be placed randomly into one of two study groups: the Technology Assisted Stepped Collaborative Care Intervention Group or the Usual Care Group.
The intervention will target three of the most debilitating End State Kidney Disease (ESKD) related symptoms- fatigue, pain and depression. A stepped collaborative care approach for pharmaco and/or CBT allows for shared decision-making and individualization of treatment according to a patient's clinical status, preferences and treatment response. The TĀCcare 2.0 intervention will build on successful design elements of the original intervention, enhance depression management strategies and increase durability of effect by incorporating monthly longitudinal telemedicine-delivered booster sessions to complete a total 12-month intervention. Additionally, using a collaborative care approach, the patients' symptom management will be integrated with their dialysis treatment, thus increasing patient acceptability and adherence.
Eligibility Criteria:
Ineligibility Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the Technology Assisted Stepped Collaborative Care group will receive a stepped-approach for pharmaco and/or Cognitive Behavioral Therapy (CBT) and individualization of treatment to improve symptoms of fatigue, pain and/or depression, in a real-world setting.
Behavioral: Technology Assisted Stepped Collaborative Care
Participants in the Usual Care Group will continue with their usual care.
Other: Usual Care Arm
The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.
Participants in the Usual Care Arm will continue with their usual care.
TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome)
Change in fatigue is a primary outcome. The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) will be used to measure fatigue. Scores range from 0-52 with lower scores indicating greater fatigue.
Time frame: 6 months
TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome)
Change in pain intensity score is also a primary outcome measure. The Brief Pain Inventory (BPI) will be used to measure pain intensity. The BPI uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.
Time frame: 6 months
TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome)
Change in depression severity score is also a primary outcome measure. The Beck Depression Inventory-II will be used to measure the depression severity score. Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.
Time frame: 6 months
Fatigue
Change in fatigue measured by The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F). Scores range from 0-52 with lower scores indicating greater fatigue.
Time frame: 3 and 12 months
Pain Intensity
Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.
Time frame: 3 and 12 months
Depression
Change in depression severity score using The Beck Depression Inventory-II (BDI-II). Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.
Time frame: 3 and 12 months
Pain interference
Brief Pain Inventory will be used to measure interference due to pain. Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores indicate worse pain interference.
Time frame: 3, 6 and 12 months
Dialysis Symptom Burden
Dialysis symptom burden and severity will be assessed using the Dialysis Symptom Index (DSI). The total score can range from 0 to 150, with higher scores indicating a greater symptom burden.
Time frame: 3, 6 and 12 months
Self-Efficacy for Managing Chronic Conditions
The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions Short Form 8A will be used; higher scores indicate greater self-efficacy in managing chronic conditions.
Time frame: 3, 6 and 12 months
Sleep quality
PROMIS Sleep Disturbance and sleep duration questions will be asked to assess sleep quality. The scale consists of 6 items with a 5-point response scale. Higher scores indicate greater sleep disturbance.
Time frame: 3, 6 and 12 months
Post Dialysis fatigue
Single Item Question asking patients length of time it takes to recover from dialysis treatment will be used to assess post dialysis fatigue. Higher recovery time indicates greater post dialysis fatigue
Time frame: 3, 6 and 12 months
Anxiety
The Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to assess severity of anxiety symptoms. Scores range from 0 to 21 with higher scores indicating greater anxiety.
Time frame: 3, 6 and 12 months
Health related quality of life
RAND 36-Item Short Form Health Survey (SF-36) will be used to measure health related quality-of-life measures. Scores range from 0 to 100 with higher scores indicating better health status.
Time frame: 3, 6 and 12 months
Perceived Social Support
The Multi-Dimensional Scale of Perceived Social Support (MSPSS) will be used to assess patients' perceived level of social support. It is a 12 item measure that uses a 5-point Likert scale with higher scores indicating greater perceived social support.
Time frame: 3, 6 and 12 months
Adherence to dialysis treatments
Data on missed dialysis treatments will be recorded from dialysis electronic health record
Time frame: 3, 6 and 12 months
Hospitalization/ER visits
Data on hospitalizations and ER visits will be collected from the dialysis electronic health records
Time frame: 3, 6 and 12 months
Fatigue Assessment Scale
The Fatigue Assessment Scale (FAS) is scored by summing up the responses to each of its 10 items, where each item is rated on a 5-point Likert scale from "never" (1) to "always" (5), resulting in a total score ranging from 10 (minimal fatigue) to 50 (extreme fatigue) ; higher scores indicate greater fatigue severity.
Time frame: Every 4 weeks during 12 week intervention
PROMIS Anxiety SF 8A
The PROMIS Anxiety SF 8A is scored by summing up the responses to each of the 8 questions, where each question is rated on a 5-point scale (1=never to 5=always), resulting in a raw score; this raw score is then converted into a T-score using a reference table to provide a standardized measure of anxiety severity, with a mean T-score of 50 and a standard deviation of 10 across the general population.
Time frame: Every 4 weeks during 12 week intervention
PROMIS Depression SF 8A
The PROMIS Depression SF 8A is scored by summing up the responses to each of the 8 questions, where each question is rated on a 5-point scale from 1 ("Never") to 5 ("Always"), resulting in a raw score; this raw score is then converted into a T-score using a provided table to interpret the severity of depression, with higher T-scores indicating greater depression severity.
Time frame: Every 4 weeks during 12 week intervention
Visual Analog Scale (VAS) for Pain
A Visual Analog Scale (VAS) for pain is a simple pain measurement tool where a patient marks a point on a 10cm line to indicate the intensity of their pain, with one end representing "no pain" and the other end representing "worst pain imaginable"; the score is determined by measuring the distance from the "no pain" end to the mark made by the patient, usually in centimeters, providing a numerical value representing their pain level
Time frame: Every 4 weeks during 12 week intervention
Plan to share: Yes — All subject-level clinical, survey, and laboratory will be preserved and shared. Data will be deidentified before submission. The study protocol, date collection forms/case report forms, data dictionary, manual of operations, interview guides, qualitative analysis codebook and a glossary of domain-specific terms will be submitted.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Baseline data (defined as any data collected prior to any intervention), such as demographics, tabular clinical data will be submitted within 4 months after enrollment is completed and released through the repositories 4 months after that. After the study is complete and unblinded, the study team will submit all remaining scientific data to the data repositories and will update the RCT status to "complete" in clinicaltrials.gov. This data will be released 12 months after the end of the study. Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
Access criteria: To maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality, reuse of this dataset should use the following Data Use Limitations (DULs) under Controlled Access that is made available by a data repository only after approval of the request by the repository's independent review panel process.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2029, 46 months after the start.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 46 months is above that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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Renal Insufficiency, Chronic →