What is Polycystic Kidney Disease PKD

Polycystic kidney disease (PKD) is a progressive, genetic disorder of the kidneys. It occurs in humans and other organisms. PKD is characterised by the presence of multiple cysts (...

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Tolvaptan
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http://www.clinicaltrials.gov/ct/s...


Phase III clinical trial has started enrolling for the drug Tolvaptan. It is showing that it has stopped the progression of the disease and shrinking the cysts resulting in less renal pain and discomfort.

"autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic disorder characterized by the formation of fluid-filled cysts in the kidneys. The accumulation of these cysts enlarges the kidneys, impairing renal function and may lead to renal failure requiring dialysis or transplantation. This disease can be life-threatening. Aside from early antihypertensive control and dietary protein restriction, which may offer a modest degree of protection, most surviving patients require renal replacement therapy (dialysis and transplant) and suffer from high morbidity and mortality.2 Tolvaptan is an oral vasopressin (water regulating hormone) inhibitor acting principally at the kidney cells affected by ADPKD. A rationale for use of tolvaptan in ADPKD is supported by research conducted in a variety of animal models. In these models, tolvaptan is effective in halting or reversing the progression of this renal disease. ,

The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing total renal volume and other important consequences of the disease."
Posted on 05/01/07, 02:05 pm
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Reminder: This is a support group for Polycystic Kidney Disease (PKD). We trust you will do your best to remain positive and helpful. For more information, see our rules of the road.

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Reply #1 - 05/01/07  11:06pm
" are you thinking of participating in this clinical trial? "
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Reply #2 - 05/02/07  2:18am
" What do you mean? "tolvaptan is effective in halting or reversing the progression of this renal disease"

Are you saying that this drug can stop this disease right where its at? We wont get any more cyst or have to have dialysis or transplants? Sorry i know i sound dumb but is that what its suppose to do stop the disease from going any further or does it just slow down the progress of the disease? My doctor told me about some study they had going and the drug was suppose to help shrink the size of cyst but she said you still get new cyst that develop they just dont get as big and it slows down the speed of how fast they grow ... Who knows are you gonna try and join in on the study?? My doctor doesnt want me to do any study's not sure why... "
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Reply #3 - 05/02/07  10:29am
" Yes, it is said to stop the progression, no dialysis, no transplant. It is also said to shrink all the cycts to ease the pain and discomfort. The FDA has granted it a fast track through the FDA because its a potential life saving drug, not a cure, but life saving. I would love to be in the trial but I work full time and I am not sure how often I will need to have tests done, if its to the hospital once a day or once a week, the only way I would be able to be in the clinical trial is if I would be able to work full time to. So I emailed the lady and asked her for more info. "
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Reply #4 - 05/02/07  8:22pm
" this is very good news, so this drug will be on teh market soon? "
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Reply #5 - 05/02/07  11:49pm
" Well, In February 2006 it was granted a fast track by the FDA and was supposed to be pushed through in 6 months. Its been over a year so that did not happen!! But they are in Phase III clinical trials so that should be the last phase. Sometimes they go a phase further if need be, but hopefully they will not have to. I love to see it out sometime this year, but I dont know how long the trial lasts for. I have emailed the contanct lady to get some info because I would love to be in the trial. "
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Reply #6 - 01/09/08  5:00pm
" I just got my letter about a month ago about joining now. Have you heard back and have you applied? I am waiting to hear back right now. The person at my closest facility was away til mid January so I am trying to be patient....but I really want to do this. I cannot take the pain and pressure anymore. "
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Reply #7 - 01/15/08  6:00pm
" just wondering...has ANYONE tried to get on this trial or is anyone here on this?? Please let me know if you have heard anything!! Thanks! =) "
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Reply #8 - 01/27/08  4:16pm
" I've been watching for more news on this medication. Have a question though. It said for fluid-filled cysts. On my medical report my cysts are filled with blood. Would it work for me? "
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Reply #9 - 01/31/08  8:21am
" They have my reports and my disc with all my tests and I got the call yesterday to schedule to go in for my screening but it lookslike I am in if I want to be!! =) I am calling in to get more info today and I will post what I find out.....and Lettetalk, yes I believe that is the same. My cysts are also considered hemmorhagic or blood filled. Okay, calling right now, wish me luck!! =) "
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Reply #10 - 01/31/08  8:34am
" Crap crap crap!!! I have to get another ultrasound done to see the progression and the total volume. I guess the US done in march of 06 only had my total volume at just under 600 and it needs to be at 750 or at least really close...ugh!! Welp, I am off to beg my nephrologist for yet another test. "
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