Sunday, November 23, 2014

HALT - PKD Clinical Trial Results

PKD Research

From MedicalXpress

Two drugs are no more effective than one to treat common kidney disease

Two drugs are no more effective than 1 to treat common kidney disease


Using two drugs was no more effective than a single drug in slowing disease progression in people with autosomal dominant polycystic kidney disease (ADPKD), according to two studies funded by the National Institutes of Health (NIH). One of the studies also showed that rigorous blood pressure treatment slowed growth of kidney cysts, a marker of ADPKD, but had little effect on kidney function compared to standard blood pressure treatment.

The results of the HALT-PKD Clinical Trials Network studies will be published online November 15 in two papers in the New England Journal of Medicine to coincide with presentation at the American Society of Nephrology annual meeting.

"Enlarged cysts in kidneys can lead to reduced kidney function and eventually kidney failure, where the only treatment is dialysis or transplantation," said study author Michael Flessner, M.D., Ph.D., a program director at the NIH's National Institute of Diabetes and Digestive and Kidney Diseases, which funded the trial. "The HALT-PKD findings show that people with polycystic kidney disease do not need to take both of the drugs studied to slow their rate of kidney cyst growth and decline in kidney function."

The HALT-PKD trial enrolled volunteers to test whether a combination of commonly used FDA-approved drugs, lisinopril and telmisartan, could shrink kidney cysts and therefore slow progression of ADPKD, a genetic disorder characterized by growth of fluid-filled cysts in the kidneys. Within the trial, one study examined 558 people with early-stage ADPKD and relatively healthy kidneys. The other study treated 486 people with more advanced disease and decreased kidney function. In each study, half of participants were randomly assigned to receive lisinopril and telmisartan, while the other half received lisinopril plus a placebo. In both studies, adding the second drug did not change kidney function or rate of increase in kidney cyst size.

In the study of people with early ADPKD and healthy kidneys, researchers also tested if decreasing blood pressure below usual targets would slow progression of ADPKD and preserve kidney function. High blood pressure is a common and damaging effect of ADPKD. Half the participants were assigned to a standard blood pressure group (between 120-130 over 70-80), and half to a lower blood pressure group (between 95-110 over 60-75) but still within the normal range.

Participants in the lower blood pressure group received more rigorous treatment, taking more medication to maintain a lower blood pressure. The lower blood pressuregroup had a 14 percent decrease in kidney cyst size compared to those in the standard blood pressure group. However, kidney function - measured by estimated glomerular filtration rate (eGFR) - was about the same as the standard group at the end of the trial, yielding no clinical benefit. About 15 percent more of the people in the lower blood pressure group experienced lightheadedness and dizziness.

"The HALT-PKD studies were well performed and the largest of their kind," said Robert Star, M.D., director of the Division of Kidney, Urologic, and Hematologic Diseases within NIDDK. "More research is needed to better understand how polycystic kidney disease destroys kidney function over time, and what combination of medications can most safely and effectively prevent or undo the damage caused by this devastating condition."




From The Times of India, by Manash Pratim Gohain


Scientists at IIT-Bombay have developed a special membrane that promises to reduce the cost of dialysis by 50%, cut down time taken for the process by half and be safer for the patient. It could also spur development of portable or wearable dialysers.

Dialysis is the process of artificially removing waste and excess water from the blood in people suffering from chronic kidney failure. Due to the high cost of the procedure, around 90% of those who develop kidney failure in India die within months because of lack of treatment, according to an AIIMS study.

That could change in the coming years, with researchers at IIT-B's chemical engineering department hoping that their product will be available in the next three years. The hollow-fiber membrane developed by them has completed laboratory tests and awaits pre-clinical trials.

An Indian patent has been procured for the product. An indigenous and low-cost pilot plant for production of these membranes has also been functioning for the last two years.





From PKD Foundation

Active Studies – Not Yet Recruiting

For drugs and therapies to be developed for PKD, clinical studies must be conducted. Patients play a key role in the research and development process by volunteering to participate in clinical studies. From observational studies to clinical trials, you can help researchers unlock the secrets of PKD and find a treatment by participating in a study.

Minnesota
New Quantitative MRI Parameters in Assessing Kidneys of ADPKD (MRI Pilot)

International
Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD (GeneQuest)
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease (PKD) Transplanted Recipients (EVERKYSTE)
Lanreotide in PKD Study (LIPS)

Not Listed
Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan in Subjects With ADPKD





Living With PKD

From Nephrology News, By Rebecca Zumoff

Frequent home dialysis provides survival advantage over in-center hemodialysis

Frequent home dialysis therapies may help prolong the lives of patients with kidney failure compared with hemodialysis treatments administered in medical centers, according to a study presented at ASN Kidney Week 2014.

Researchers led by Austin Stack, MD, MBBCh, FASN from the Graduate Entry Medical School, University of Limerick, in Ireland, analyzed national data to compare dialysis survival among 585,911 patients who started dialysis in the United States between 2005 and 2010.

Peritoneal dialysis and frequent home hemodialysis done at least six times a week offered the greatest patient survival compared to in-center hemodialysis, while home hemodialysis done only times three per week had the lowest survival rate, the authors concluded.

Among the major findings:
Patients who were treated with peritoneal dialysis were about 10% less likely to die during the study period than patients treated with standard 3-times per week in-center hemodialysis.
Patients receiving high frequency home hemodialysis delivered six times per week were 26% less likely to die during the study period than those receiving standard in-center hemodialysis.
Patients receiving less frequent home hemodialysis (four or five times per week) had mortality risks that were similar to those of patients receiving in-center hemodialysis.
Patients receiving home hemodialysis at a frequency of three times per week were 47% more likely to die than patients receiving in-center hemodialysis.

"We suggest that a treatment approach that adopts a peritoneal dialysis first or frequent home hemodialysis first strategy should be considered for all suitable patients who develop end stage kidney disease," said Dr. Stack. "Such an approach may offer superior survival, better quality of life, and be cost effective for national health care systems."

Study: "Survival Differences between Home Dialysis Therapies and In-center Haemodialysis: A National Cohort Study" (Abstract SA-PO957)

All the Kidney Week abstracts are available at https://www.asn-online.org/education/kidneyweek/archives.




From News-Medical.com

Majority of kidney dialysis patients not adequately prepared for emergency or natural disaster

But individualized education dramatically improves preparedness, Loyola study finds

Eighty percent of kidney dialysis patients surveyed were not adequately prepared in the event of an emergency or natural disaster that shut down their dialysis center.

But after receiving individualized education from a multidisciplinary team of doctors, nurses, dieticians and social workers, 78 percent of these patients had become adequately prepared, according to a Loyola University Medical Center study.

Anuradha Wadhwa, MD, and colleagues, reported findings during the ASN Kidney Week 2014 meeting.

Patients with kidney failure rely on dialysis treatments to survive. The treatments, typically three times a week for about four hours, remove wastes and extra fluids from the blood.

Researchers surveyed 124 patients at a Loyola outpatient dialysis center. During dialysis sessions, patients were asked whether they:

Believed they were prepared for an emergency.

Had an emergency plan they had discussed with a family member or dialysis unit.

Knew of a back-up dialysis facility.

Were familiar with an emergency diet that is key to survival in the event of a missed dialysis session. The diet includes limiting fluid intake and avoiding potassium-rich foods.


Patients who answered yes to all four questions were considered to be prepared. But while 60 percent of the patients thought they were prepared for an emergency, the survey found that only 20 percent were actually prepared. However, 95 percent of patients were interested in learning about preparedness. [Read more]

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