Kidney, Polycystic Clinical Trial
Official title:
HALT Progression of Polycystic Kidney Disease Study B
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the
progression of cystic disease and on the decline in renal function in autosomal dominant
kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical
trials targeting different levels of kidney function: 1) early disease defined by GFR >60
mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73
m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the
first three years. Participants enrolled in Study B will be followed for five-to-eight years,
with the average length of follow-up being six and a half years.
Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an
angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
* Specific Aim of Study B
To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the
setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction
of baseline estimated Glomerular Filtration Rate (eGFR), end-state renal disease (ESRD) or
death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60
mL/min/1.73m2).
* Hypothesis to be tested in Study B
In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73
m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline
in kidney function over ACE-I monotherapy, independent of standard blood pressure control
(110-130/80 mm Hg).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00426153 -
Octreotide in Severe Polycystic Liver Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT00283686 -
HALT Progression of Polycystic Kidney Disease Study A
|
Phase 3 | |
| Not yet recruiting |
NCT00067977 -
Clinical Trial to Slow the Progression of ADPKD
|
N/A |