Dream RCTs

Water Vs Tolvaptan in Reducing ADPKD Progression

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Current total funding for this study: $89,100

Author:

Krishnam Raju Penmatsa

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)

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

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%.

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