Polycystic Kidney Disease (PKD) Support Group
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 (polycystic) in both kidneys. The disease can also damage the liver, pancreas and rarely the heart and brain.
http://www.pkdcure.org/news/treatment-for-adpkd-approved-in-canada
JINARC (tolvaptan) has been approved in Canada as a treatment for autosomal dominant polycystic kidney disease (ADPKD). JINARC was discovered in Japan by Otsuka Pharmaceutical and was first approved there for ADPKD in 2014. The Health Canada approval of JINARC is based on the results of the pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date in adults with ADPKD.
We are very excited for our ADPKD patients in Canada to have access to a treatment that slows the progression of kidney enlargement. For patients in the United States, we are hopeful this is within reach as well. Otsuka Pharmaceutical Development & Commercialization, Inc. and the United States Food & Drug Administration (FDA) have been working together to determine the most appropriate path forward. Initially, in late August of 2013, Otsuka received a Complete Response Letter (CRL) from the FDA regarding tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of a new drug application is complete and they cannot approve it in its present form without additional information.
In June 2014, Otsuka announced that patient enrollment began for a new Phase 3b study of tolvaptan for adult patients with ADPKD. The company reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design and planned analysis of this trial. This Phase 3b trial is being conducted to provide the additional information requested by the FDA.
Patients play a key role in developing treatments by volunteering to participate in clinical studies. To learn more about getting involved in this and other trials, visit pkdcure.org/research/clinical-studies
JINARC (tolvaptan) has been approved in Canada as a treatment for autosomal dominant polycystic kidney disease (ADPKD). JINARC was discovered in Japan by Otsuka Pharmaceutical and was first approved there for ADPKD in 2014. The Health Canada approval of JINARC is based on the results of the pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date in adults with ADPKD.
We are very excited for our ADPKD patients in Canada to have access to a treatment that slows the progression of kidney enlargement. For patients in the United States, we are hopeful this is within reach as well. Otsuka Pharmaceutical Development & Commercialization, Inc. and the United States Food & Drug Administration (FDA) have been working together to determine the most appropriate path forward. Initially, in late August of 2013, Otsuka received a Complete Response Letter (CRL) from the FDA regarding tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of a new drug application is complete and they cannot approve it in its present form without additional information.
In June 2014, Otsuka announced that patient enrollment began for a new Phase 3b study of tolvaptan for adult patients with ADPKD. The company reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design and planned analysis of this trial. This Phase 3b trial is being conducted to provide the additional information requested by the FDA.
Patients play a key role in developing treatments by volunteering to participate in clinical studies. To learn more about getting involved in this and other trials, visit pkdcure.org/research/clinical-studies
My son said he is young and healthy so why not give it a try. He is waiting to hear back from his doctor. I have to admit I have some concerns with it not being approved in the States first.
My understanding is that potential liver involvement is at 5% risk. Which really isn't that bad. My questions are how severe is the potential for liver damage and does it stop progression once the med is stopped???
Both of my kids have ADPKD so I would be very invested in finding out if this medication is worth the risk. We have read the online studies but really need to have these results interpreted. Hopefully one of the on call doctors at dialysis will be informative.
The explanation given is that it causes high sodium levels in the blood
Chewitt
My son has been on blood pressure meds since he was 17. His function is still pretty good.
It is too late for me to get benefit from this drug. I am on dialysis now. But I sure would like to see something come out that would help my children. I dread the thought of either of them suffering the pain that I do.
Chewitt
The Splendid Medical Values of Turmeric
*Turmeric can relieve the swelling, which is common in polycystic kidney disease and remove toxins and inflammation.
* Turmeric has the magic function of promoting fluid contraction and inhibiting the secretion of kidney cysts - Colagogue effect.
* Turmeric has the function of relieving stasis, belly bump, stabbing pain, anti-oxidant, anti-fungal, shrinking cysts and improving kidney function .
Starting at year 40... my age, theoretically my kidney volume/size at age 60 on the drug is the same at age 50 with no drugs. eGRF decline savings( -2.1 vs -0.71 yearly) are even greater... age 47 naturally with PDK == age 60 on drugs! This is with a starting eGRF of 85 that I have now.
No, of course there are the side effects which impact every person to a different degree.
If I can handle the side effects, and delay my kidney failure 10+ years, I think the choice should be mine to at least try the drug... if health care will cover the costs to monitor my blood levels/liver when on it... a big ask on the health system, I know.
I am booking apt. to start the process....
PKD Foundation or Kidney Foundation of Canada noted end of May as a milestone date... closing in on that now.
There is no cost to me... insurance covers some.. and the drug company the rest. There is a support team covering Canada.. a real person to talk to. They are focused on liver function, and help in all the paperwork to get it rolling.
You have to do blood work every month to monitor the liver levels.
There are 3 doses, I am at the lowest still. ( 45AM / 15PM) Moving to the next ( 60/30) in two weeks
Very minor side effects so far.
Yes, I agree.. it only delays the problems... but when you are 55 and at failure... a few years then might look really good! Only time to make that choice is now.