An interventional study of Coaching DASH group (C-DASH) and Self-Shopping DASH group (S-DASH) in Chronic Kidney Disease and Hypertension, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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 287th largest by enrollment of the 819 interventional ones that give a count, is one of 46 that started in 2018, is one of 314 with no phase, and was the 515th 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: 21 Years to 100 Years · 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. 46 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 142 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:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 8 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.
This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.
This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD.
150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion 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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Behavioral: Self-Shopping DASH group (S-DASH)
The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Behavioral: Coaching DASH group (C-DASH)
Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
Also known as: Coaching DASH diet advice group (C-DASH)
Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
Also known as: Self-Shopping DASH diet advice Group (S-DASH)
Change in Urinary Albumin Excretion From Baseline to 4 Months
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Time frame: Baseline, 4 months
Change in Systolic Blood Pressure From Baseline to 4 Months
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Time frame: Baseline,4 months
Change in Systolic Blood Pressure From Baseline to 12 Months
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Time frame: Baseline, end of study (approximately 12 months)
Change in Urinary Albumin Excretion From Baseline to 12 Months
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Time frame: Baseline, end of study (approximately 12 months)
Change in Urinary Albumin Excretion From Baseline to 1 Month
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Time frame: Baseline, 1 month
Change in Systolic Blood Pressure From Baseline to 1 Month
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Time frame: Baseline, 1 month
| Milestone | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Started | 70 | 72 |
| Completed | 69 | 72 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Started | 52 | 56 |
| Completed | 49 | 53 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 3 |
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
| mg/g | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 4 Months | -28.6 ± 12.0 | -5.6 ± 11.6 |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| mm Hg | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 4 Months | -1.4 ± 1.8 | 0.9 ± 1.7 |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| mm Hg | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 12 Months | 1.5 ± 2.3 | -1.6 ± 2.3 |
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
| mg/g | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 12 Months | -11.5 ± 14.1 | -1.4 ± 13.7 |
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
| mg/g | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 1 Month | -14.8 ± 10.1 | -19.6 ± 9.8 |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| mm Hg | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 1 Month | -1.1 ± 1.6 | -0.3 ± 1.5 |
Collected over The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | 0/70 (0%) | 7/70 (10%) | 10/70 (14.3%) |
| Self-Shopping DASH Group (S-DASH) | 0/72 (0%) | 7/72 (9.7%) | 16/72 (22.2%) |
| Event | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Abdominal PainGastrointestinal disorders | 1/70 | 0/72 |
| Angioneurotic edemaInjury, poisoning and procedural complications | 1/70 | 0/72 |
| Acute kidney failureRenal and urinary disorders | 1/70 | 0/72 |
| Chronic pancreatitisGastrointestinal disorders | 1/70 | 0/72 |
| COVID-19Infections and infestations | 1/70 | 0/72 |
| Diabetes mellitus with ketoacidosisEndocrine disorders | 1/70 | 0/72 |
| Mechanical complication of ventricular intracranial (communicating) shuntNervous system disorders | 1/70 | 0/72 |
| Moderate persistent asthma with (acute) exacerbationRespiratory, thoracic and mediastinal disorders | 1/70 | 0/72 |
| Acute Kidney InjuryRenal and urinary disorders | 1/70 | 0/72 |
| Angina pectorisVascular disorders | 1/70 | 0/72 |
| Event | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Hypertensive UrgencyVascular disorders | 3/70 | 10/72 |
| HypokalemiaMetabolism and nutrition disorders | 7/70 | 6/72 |
| Age, Continuous(years) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 59.7 ± 13.7 | 62.7 ± 11.7 | 61.1 ± 12.8 |
| Sex: Female, Male(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Female | 50 | 40 | 90 |
| Male | 20 | 32 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 69 | 71 | 140 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 69 | 71 | 140 |
| White | 0 | 0 | 0 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| United States | 70 | 72 | 142 |
| Baseline Urinary albumin-to-creatine (ACR)(mg/g) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 99.8 (49.0 to 234.5) | 98.8 (47.3 to 236.5) | 99.5 (4.08 to 234.5) |
| Systolic Blood Pressure(mmHg) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 128.1 ± 14.4 | 130.8 ± 12.8 | 129.4 ± 13.6 |
| Diastolic Blood Pressure(mmHg) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 72.3 ± 10.6 | 74.4 ± 11.2 | 73.3 ± 10.9 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Plan to share the Statistical Analysis Plan and Study Protocol.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available after one year after final data collection.
Access criteria: Will release de-identified information per request via Johns Hopkins agreement.
Ran from Feb 2018 to primary completion in Nov 2021, 45 months.
Results were first posted in Jun 2023, 1 year 7 months after primary completion.
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 45 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.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →