Clinical Trials: Completed Studies

Completed Studies

Adrenal Functions in ADPKD

Intervention:	Drug - Tetracosactin
Sponsor:	Istanbul University
Status:	Completed
Results:	No information available at this time.

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention:	Water Prescription
Sponsor:	University of Kansas
Status:	Completed
Results:	In animal studies of ADPKD, giving the animal large amounts of water suppresses vasopressin levels in the blood and cyclic AMP levels in the kidneys, slowing cyst enlargement. This study tested whether water ingestion is a potential therapeutic strategy in people with ADPKD. This study was designed so that water intake for each individual was calculated so that urine solute concentration reached a specific target level of 285 mOsm. Five of the eight individuals enrolled in the study were able to achieve a urine osmolality of 285 mOsm. (Osmolality is a measure of solutes in the urine.) The success of this study shows that a quantitative method to determine the amount of water intake needed for a given individual to achieve a target osmolality can be calculated. Several limitations of the study were acknowledged by the researchers. First, the sample size was much smaller than required for a clinical trial because a methodology was being developed and validated. The effect of water intake on the course of the disease was not tested. Secondly, the small sample size included almost all Caucasian women. Daily solute intake, urine solute concentration and blood levels of vasopressin vary by race and gender, so these findings cannot be generalized to a more diverse population. Thirdly, study participants had normal blood pressure with GFRs in chronic kidney disease stages 1 and 2. NOTE: For those with advanced kidney disease (stages 3, 4 & 5) it is important to not increase fluid intake above normal. Whether or not water intake can affect the course of ADPKD by lowering vasopressin levels in the kidney is a critical factor that must be studied further.

Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients with ADPKD

Intervention:	Drug - Everolimus
Sponsor:	Novartis
Status:	Completed
Results:	Patients with large kidneys and renal dysfunction were studied to determine whether everolimus slows the increase in total kidney volume in patients with ADPKD. The baseline kidney volumes were 2028 cc in the control group and 1911 cc in the everolimus-treated group. GFR was approximately 50% of normal in both groups at the start of the study. Compared to placebo, everolimus slowed the rate of increase of total kidney volume during the first year of the study but this significant effect was not maintained after 2 years, perhaps because of the high participant drop-out rate. The authors conclude that everolimus appears to retard the growth of kidneys in ADPKD patients but does not slow the decline in progressive renal impairment. Everolimus treatment wais associated with a high rate of side effects, similar to those seen in patients after kidney transplantation who took the drug to suppress rejection.

Lanreotide as Treatment of Polycystic Liver Disease

Intervention:	Lanreotide
Sponsor:	Radboud University
Status:	Completed
Results:	No information available at this time.

Effects of NO-inhibition on Renal Hemodynamics in Patients with PKD and chronic Glomerulonephritis

Intervention:	Drug - Ng-monomethyl-L-arginine
Sponsor:	Holstebro Hospital
Status:	Completed
AResults:	No information available at this time.

Sirolimus Treatment in Patients with ADPKD: Renal Efficacy and Safety (SIRENA)

Intervention:	Drug - sirolimus
Sponsor:	Mario Negri Institute for Pharmacological Research
Study Phase:	II
Status:	Completed
Results:	This study was an 18-month, open-label, randomized, controlled trial in which researchers hoped to determine whether sirolimus halts the growth in kidney volume among patients with ADPKD. At the start of the study, total kidney volume for both control and sirolimus groups was approximately twice normal volume. Creatinine clearance was 70 ml/min in both groups. After 18 months of treatment, sirolimus did not halt polycystic kidney growth.