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Dream RCT Initiative

Welcome the DreamRCT initiative. Below are fantasy trials created by nephrologists from around the world. Please vote on the relevance of the trial by using fantasy money. Who knows? Perhaps an investigator will get some inspiration and decide do it! Simply login and UKidney will provide you $100,000 in virtual money to spend.

Or, how about you submit your own now 

Plasma-Exchange for Cast Nephropathy: A Randomized Controlled Trial

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Current total funding for this study: $1,413,103

Author:

KD Jhaveri

About Author:

Nephrologist

Study Acronym:

CAST-AWAY

Study design / outcomes

Hypothesis: Plasma exchange or high flux dialyzers improve recovery of renal function in patients with cast nephropathy

Introduction: Prior studies have looked at the question of using plasma exchange in myeloma patients with cast nephropathy. The largest previous RCT did not use biopsies to assure that they were treating cast nephropathy and the outcome was equivocal. Also, no studies have been done in the modern era of better chemotherapy agents

Design: Randomized controlled trial 

Arm 1: Standard chemotherapy only 

Arm 2: Standard chemotherapy + TPE 

Arm 3: Standard chemotherapy + high flux dilalysis

Outcome Measures: Independence of HD at 3 months. Change in GFR

Secondary Outcome Measures: Efficiency of plasma exchange in respect to reduced sFLC levels. Duration of HD to renal recovery. Hospital days. Death/Mortality. 

Study Population: Patients with BIOPSY proven cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma 

Inclusion Criteria: Age >= 18 years Dialysis dependent acute renal failure, fulfills diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma, abnormal serum FLC ratio and a sFLC concentration > 500 mg/L --- MOST IMPORTANT ---kidney biopsy proven (cast nephropathy)

Exclusion Criteria: CKD IV, V at baseline Prior history of MM on chemotherapy Other biopsy findings( LCDD, amyloidosis, cryo. etc) Cannot tolerate HD due to cardiac status or hemodynamics Hematologic contraindications to TPE

Modulating MAGnesIum and K (potassium) in dialysate: a pragmatic cluster randomised controlled trial

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Current total funding for this study: $1,179,989

Author:

Swapnil Hiremath

About Author:

Nephrologist

Study Acronym:

MAGIK trial

Study design / outcomes

To try to prevent sudden cardiac death we will randomize dialysis centers to either usual care or individually adjusted potassium and/or magnesium.

This is a 2x2 factorial design with centers randomized to:

  1. Usual care
  2. Usual potassium and algorithm driven magnesium
  3. Usual magnesium and algorithm driven potassium
  4. Algorithm driven potassium and magnesium

The primary outcome will be all-cause mortality.

Secondary outcomes will include: - difference in cardiovascular mortality - difference in sudden death (within cardiovascular mortality) - hospitalization for any reason

Can albuminuria reduction improve cardiovascular and renal health?

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Current total funding for this study: $406,999

Author:

Jordan Weinstein

About Author:

Nephrologist

Study Acronym:

CLARITY trial

Study design / outcomes

Hypothesis: Reduction in urinary albumin by escalating dosages of an ARB or by combination therapy of ARB plus eplerenone can reduce residual renal and cardiovascular risk associated with ongoing albuminuria in patients with type 2 diabetes mellitus.

Inclusion criteria: Patients > 18 years old with type 2 diabetes mellitus on either an ACE inhibitor or ARB with a PCR of 500 mg/g to 1000 mg/g at enrollment. 

Design: Patients with proteinuria between 500 mg and 1g per day and GFR 45-60 ml/min will be randomized in open-label fashion to 1 of 2 groups.

  1. “Usual care”, using patients’ enrollment ACE inhibitor or ARB. Blood pressure is maintained <130/80 by any means except by increasing ACE or ARB.
  2. Escalation of patient’s enrollment ACE or ARB by forced titration until PCR falls to the 200 or less or until it does not respond to 2 consecutive titrations. The physician may optionally add eplerenone to attempt further reduction in albuminuria. In order to prevent hyperkalemia as a cause for withdrawal from the study, all patients are prescribed the potassium binder Patiromer. Additional medications other than ACE inhibitors, ARBs or aldosterone blockers may be added to maintain BP <130/80.

Follow-up: Patients continued on study protocol for 5 years

Primary Outcomes: Doubling of serum creatinine, ESRD or death

Secondly Outcomes: Composite of myocardial infarction, coronary revascularization, sudden death or stroke

Is Loop Diuretic Use in End Stage Renal Disease Really Safe? No-Diuretics versus Diuretics for Euvolemia in Hemodialysis Trial

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Current total funding for this study: $226,600

Author:

John Wigneswaran

About Author:

Nephrologist

Study Acronym:

NO DUH Trial

Study design / outcomes

NO DUH Trial is a three arm, double blind, placebo control, multi-center trial. Incident dialysis patients with at least 360 mL of urine a day are randomized to:

  1. Placebo
  2. Diuretic 1: Furosemide at 80 mg twice a day but then titrated up to maximize urine output (up to 500 mg per day) without going below a doctor established “dry weight”. Investigators would be encouraged to keep these patients euvolemic based on clinical judgment.
  3. Diuretic 2: Furosemide at 80 mg twice a day with no adjustment for urine output or renal function.

Patients would be randomized to the three arms at a 2:1:1 ratio so that half of the patients receive diuretics and then the two different diuretic strategies would be tested.

Outcomes:

  • Time until first hospitalizations (could be surrogate for mortality)
  • Number of hospitalizations and length of stay
  • Quality of life
  • Intradialytic weight gain
  • Residual renal output
  • Neurohormonal measures (Renin, Aldosterone, Endothelin-1, Catecholamines)
  • Blood pressure (Number of medications, dosage)
  • Echocardiogram (Baseline, 1 year)

Nephrologist-driven – RRT Usual, Late, or Early Start for acute kidney injury

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Current total funding for this study: $280,500

Author:

Sarah Faubel

About Author:

Nephrologist

Study Acronym:

Nephro-RULES AKI

Study design / outcomes

This is trial that tries to rewrite the rules of nephrology trials by moving the research out of the hands of a few academic centers and put it the hands of individual nephrologists.

In this case the subject is the timing of dialysis in AKI. A distributed network of nephrologists would rapidly randomize 2,000 AKI ICU patients to either early dialysis or usual care.

The primary endpoint is mortality at 90 days in patients with AKI in the intensive care unit (ICU). Kidney function recovery is a secondary endpoint.

Acidosis in CKD­ Treatment Now Study

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Current total funding for this study: $432,399

Author:

Matt Sparks

About Author:

Nephrologist

Study Acronym:

ACT Now

Study design / outcomes

Primary study question­ Does treating mild acidosis with either sodium bicarbonate or a diet rich in fruits and vegetables impact total mortality in patients with advanced CKD (eGFR of 15­-30)? 

Primary Outcome: 

Total Mortality 

Secondary study questions­ Does treating mild acidosis result in delay in initiation of RRT for ESRD or result in an improved quality of life? 

Secondary Outcome:
RRT for ESRD, Albuminuria Hospitalization, Quality of Life Score, Cost of Care Analysis 

Inclusion Criteria 

>Age 50
CKD with creatinine based eGFR <30 using CKD­Epi equation documented on 2 visits >6 months apart.
Serum bicarbonate <22 mmol/L 

Exclusion Criteria. 

  • acute kidney injury
  • planned to start RRT within next 3 months
  • decompensated heart failure
  • already on sodium bicarbonate therapy
  • terminally ill
  • active treatment for malignancy
  • acute diagnosis of primary glomerular disease with active biologic therapy or immunosuppressive therapy

Randomization.
Patients will be randomized into three arms:

  1. Sodium Bicarbonate Group: ­Patients will be provided with sodium bicarbonate tablets 500mg TID to be taken throughout study.
  2. Fruits and Vegetable Group­: Fruits such as apples, apricots, oranges, peaches, pears, raisins, and strawberries were predominantly provided. Vegetables such as carrots, cauliflower, eggplant, lettuce, potatoes, spinach, tomatoes, and zucchini will be provided to participants on a weekly basis. q6 month classes will be held to discuss recipes and tips for increasing consumption. q6 month food diary for all participants. Furthermore, dietary acid load will be calculated as described in this paper. 
  3. Placebo Group­: Placebo with rescue therapy with oral sodium bicarbonate at a level of 16 mmol/L

Prospective Assessment of Nephropathy due to Intravenous Contrast: a Randomized Controlled Trial

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Current total funding for this study: $294,000

Author:

Chi Chu

About Author:

Resident (Other)

Study Acronym:

Panic Trial

Study design / outcomes

Believe it or not, well done retrospective trials are unable to demonstrate renal risk from IV contrast. This goes against decades of clinical practice. This needs to be adjudicated once and for all.

This trial will enroll stable outpatients with CKD stage 3b-4 to receive contrast or not. There would be no associated imaging. Serum creatinine would be measured pre-exposure and daily for up to one week post-exposure. In this setting, a rise in creatinine is far less likely to be due to alternative explanations for AKI, which are numerous in unstable hospitalized patients.

The primary outcome would be development of AKI as determined by an increase of 0.3 mg/dl or 50% increase in creatinine.

So there you have it. Contrast nephropathy - is it real? Or just a #DreamRCT?

Potassium in hemodialytic Death Study

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Current total funding for this study: $103,000

Author:

Graham Abra

About Author:

Nephrologist

Study Acronym:

PhD

Study design / outcomes

Observational data have shown that both lower and higher serum potassium are associated with mortality in hemodialysis patients. The standard response to hyperkalemia is to lower the dialysate potassium. Unfortunately, low dialysate potassium is associated with increased mortality.

In my DreamRCT hyperkalemic dialysis patients would be randomized to one of the new potassium binders (ZS-9 and patiromer) or placebo.

The primary outcome is sudden cardiac death.

Secondary outcomes would include hospitalization for hyperkalemia, hospitalization for arrhythmia, new arrhythmia diagnosis, and questionnaire defined potassium intake.

No hyponatremia modification in asymptomatic hyponatremia

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Current total funding for this study: $523,499

Author:

Joel Topf

About Author:

Nephrologist

Study Acronym:

NoLoNaMo

Study design / outcomes

Hospitalized patients with a sodium between 125 and 130 would be randomized to either active treatment to restore a normal sodium or no treatment. These patients would then be followed for the following year on the same protocol with the active arm continuing to get interventions to correct the sodium while the control arm would not have the sodium actively modified.

The outcomes are: mortality, hospitalization, quality of life, falls, bone mineral density, and cost of care. Analysis would be by intention to treat, with a goal of finding non­inferiority of no treatment.

Social media in nephrology education and training

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Current total funding for this study: $175,600

Author:

Nikhil Shah

About Author:

Nephrology Resident/Fellow

Study Acronym:

SONNET

Study design / outcomes

This is a randomized study to see if bringing social media into a nephrology fellowship improves educational outcomes. 

Question – Does systematic supplementation of local nephrology program education by a Nephrology Social Media Internship running concurrently improve the confidence and knowledge of first year nephrology fellows versus those fellows who do not receive systematic exposure. Inclusion criteria – All nephrology fellows joining in the first year of their nephrology training in North America. 

Randomization- 1:1 randomization to Nephrology social media internship in addition to regular training vs regular training only. 

Intervention • Students in the social media arm would receive: a curated biweekly list of discussions on social media, regular contributions to websites/blogs, exclusive access to specialized websites like ukidney.com which curate nephrology content 

Assessments of Fellows / Quantitative Data • quarterly evaluations in the form of examinations and an annual examination at completion of one and two years • Attitude Scale and self reported surveys - Fellows self evaluation of self confidence and competence. • All fellows will be followed up at 2 years and 5 years after graduation 

Primary Outcomes • Outcomes of Module Assessment Grades and Final Examinations and fellows self reported surveys at 1 year and 2 years. 

Secondary Outcomes • Number of research papers/ abstracts, posters presented • Survey of satisfaction and enthusiasm for nephrology • Additional fellowships eg Transplant, Research, Dialysis, Hypertension, Interventional Nephrology pursued.

Mindfulness-based stress reduction Intervention for improving Nutritional status and Depression Study

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Current total funding for this study: $267,000

Author:

Scherly Leon

About Author:

Nephrology Resident/Fellow

Study Acronym:

MIND Study

Study design / outcomes

Depression is the most common psychological problem in patients undergoing dialysis. My DreamRCT is a multi-center, randomized controlled trial to study the effect mindfulness-based stress reduction (MBSR) on nutritional status and depression in end-stage renal disease (ESRD) patients on hemodialysis. 

Patients on dialysis with depression will be randomized 1:1 to usual care versus usual care plus MBSR. Nutritional and depression assessment will be done at 3, 6 and 12 months.  

Outcome measures: • Quality of life • Hospitalization(related primarily to depression or to a medical problem) • Suicides or suicide attempts • Compliance with hemodialysis treatment • Number of withdrawals from dialysis treatment • Number of withdrawals from the treatment intervention • Adverse events potentially attributable to the intervention or control treatment • All-cause mortality

Weight Reduction Prior to Kidney Transplantation

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Current total funding for this study: $133,000

Author:

Hector Madariaga

About Author:

Nephrology Resident/Fellow

Study Acronym:

WREP-KT Trial

Study design / outcomes

The aim of this proposal is to conduct a prospective, randomized trial to assess the effect of weight loss on kidney transplant outcomes. We will test whether weight loss with a fitness program plus diet or bariatric surgery is superior to usual treatment. 

Inclusion Criteria • >Age 18 • Pre-emptive kidney transplant candidates, living related and deceased donors. • Patients that have been on hemodialysis or peritoneal dialysis for more than 6 months. •  

Patients with BMI >40 Intervention Patients will be randomized into one of three arms: 

  1. Fitness Program- Patients will be provided with an exercise program and fitness trainer.
  2. Bariatric surgery- Patients that qualify and are good candidates for bariatric surgery (restrictive, malabsorptive or combination procedures) will also be enrolled. After 10 months post-bariatric surgery, patients will be selected for kidney transplant surgery. 
  3. Control Group- Treatment as Usual (Patient will be provided with information about weight loss programs and plans without direct supervision) 

Primary end points • Delayed wound healing. • Delayed graft function • 1 year graft survival 

Secondary end points • Perioperative complications • Allograft rejection (cellular or antibody-mediated) • Hospital length of stay

Immunosuppression for Drug-Induced Interstitial Nephritis

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Current total funding for this study: $141,900

Author:

Gearhoid McMahon

About Author:

Nephrologist

Study Acronym:

IDIN

Study design / outcomes

Acute interstitial nephritis causes acute kidney injury. Treatment varies from nephrologist to nephrologist because one group reads the literature and decides that steroids are best. Others read the same literature and say there is no conclusive evidence for steroids. Others read the literature and throw their hands in the air in frustration.

This study is for all three of those groups. All patients with AKI due to suspected AIN will undergo a renal biopsy in the absence of specific contraindications. Given the fact that the clinical criteria for AIN are not well defined currently, this would mean that many patients who did not have AIN could potentially have biopsies. This can be justified because currently, the definition of AIN is generally clinical and it would provide valuable information about the accuracy of clinical AIN diagnosis while simultaneously providing clinical correlates of AIN for better diagnosis in the future.

Patients with biopsy-proven AIN would be randomized 1:1 to steroid (1mg/kg prednisone to a maximum of 60mg daily) for 2 weeks followed by a taper over 2 months or placebo.

The primary outcome of this study would be dialysis dependence at 3 months.

Acute Kidney Injury – Restoring Perfusion with ACE-Inhbition trial

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Current total funding for this study: $472,001

Author:

F. Perry Wilson

About Author:

Nephrologist

Study Acronym:

the AKI - REPACE trial

Study design / outcomes

This is a 9,000 individual, randomized, placebo-controlled, parallel-group clinical trial of enalaprilat versus placebo for the treatment of hospital-acquired acute kidney injury.

Fear of further reducing glomerular filtration rate in the damaged kidney has led nephrologists to avoid the use of ACE-inhibitors in patients with AKI. While ACE-inhibitors do indeed decrease glomerular filtration rate, they increase renal blood flow by dilating the efferent arteriole, which supplies the vasa recta. The cells in the renal medulla are particularly susceptible to ischemic insult due to the hypoxic environment created by low blood flow through the vasa recta, even under normal circumstances. In AKI, these cells begin to undergo hypoxic and ischemic damage. By treating with ACE-inhibition in early AKI, we will increase medullary blood flow, restoring some of these cells to aerobic respiratory status and thus improve patient outcomes.

Given that ACE-inhibition is expected to increase serum creatinine and possibly dialysis rates, this study is powered to detect a difference in all-cause inpatient mortality of 2 absolute percentage points. Assuming a baseline risk of mortality of 10%, we will be powered to detect a relative risk reduction of 20%.

Trial of alkali for prevention of recurrence of calcium phosphate stones

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Current total funding for this study: $831,006

Author:

David S. Goldfarb

About Author:

Nephrologist

Study design / outcomes

Calcium phosphate stones are not uncommon, making up about 15-20% of all calcium stones. The cause of calcium phosphate stones is often obscure but usually is related to a high urine pH. Treatment of calcium phosphate stones is controversial because the use of citrate is not backed by any trials. This controversy about the use of alkali is long-standing. 

My dream RCT is not difficult then to imagine. Patients with recurrent calcium phosphate stones would be included. The participants would then be randomly assigned to one of 2 regimens: usual care plus placebo or usual care plus 20 mEq of potassium citrate twice a day. 24h urine collections, CT scans and stone episode questionnaire would be performed yearly. All stone episodes including emergency room visits and urological interventions and spontaneous stone passage would be recorded. The primary outcome would be the recurrence of new stones, both asymptomatic and symptomatic.

Role of Rituximab Only in Lupus Nephritis

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Current total funding for this study: $378,995

Author:

Paul Sufka

About Author:

Rheumatologist

Study Acronym:

RoRo-LuN

Study design / outcomes

Previous studies looking at the role of rituximab for the treatment of lupus nephritis have been criticized for poor design. Initial data from the RITUXILUP group (rituximab and IV methylprednisolone on days 1 and 15 with background MMF but no oral steroids) have been promising, but many patients cannot tolerate MMF, and the role of rituximab as monotherapy given over 6 month intervals remains uncertain. RoRo-LuN would randomize patients with biopsy proven WHO class III or IV lupus nephritis to one of three arms to be followed over 2 years. The primary endpoint is renal remission defined as normal creatine or return to baseline creatinine, inactive urinary sediment, and urine protein/creatinine ≤0.5. 

The interventions: Group 1: rituximab without oral steroids (rituximab 1 g on weeks 0 & 2, 26 & 28, 52 & 54, 78 & 80, IV methylprednisolone 1 g on weeks 0 and 2); group 2: same as group 1 but with the addition of tapering oral steroids over 6 months; group 3: standard therapy (initial pulse steroids, MMF, tapering oral prednisone).

Water Vs Tolvaptan in Reducing ADPKD Progression

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Current total funding for this study: $89,100

Author:

Krishnam Raju Penmatsa

About Author:

Nephrologist

Study Acronym:

WATSAPP

Study design / outcomes

WATSAPP trial is a three arm, double blinded,randomized, multi centre 2 year trial to answer the question whether increased water intake is effective in reducing ADPKD cyst size and progression. 1500 patients of ADPKD with estimated creatinine clearance greater than 60 ml per min and baseline kidney volume of 750 ml or more will be randomized to receive:

  1. Placebo
  2. Tolvaptan twice daily (30-90 mg as tolerated)
  3. Water intake alone (3L-4L per day) (justification for water intake volume here)

Outcome measures:

  1. Change in kidney volume
  2. Change in creatinine clearance
  3. Worsening Hypertension (need for stepping up to 1 or more anti hypertensive than required at baseline)