By Laura Cowen

MedWireNews: Patients with chronic kidney disease (CKD) are commonly exposed to nocturnal hypoxia that may increase the rate of decline in kidney function, Canadian researchers report.

The nocturnal hypoxia occurs as a result of unrecognized sleep apnea, which was detected in over 40% of patients with CKD, report Patrick Hanley and colleagues from the University of Calgary in Alberta.

The researchers recruited 254 patients from outpatient nephrology clinics and hemodialysis units, all of whom completed an overnight cardiopulmonary monitoring test to determine the prevalence of sleep apnea (respiratory disturbance index ?15) and nocturnal hypoxia (oxygen saturation <90% for ?12% of monitoring).

The patients were stratified into those with an estimated glomerular filtration rate (eGFR) at or above 60 mL/min per 1.73 m²(n=55), those with CKD (eGFR<60 mL/min per 1.73 m²not on dialysis; n=124), and those with end-stage renal disease (ESRD; on hemodialysis; n=75).

As reported in Chest, the prevalence of sleep apnea increased significantly as eGFR declined, from 27% in patients with an eGFR ? 60 mL/min per 1.73 m²to 41% in those with CKD, and 57% in those with ESRD).

Of note, the prevalence of nocturnal hypoxia was similar between patients with CKD and ESRD (47% and 48%, respectively), and was significantly higher than among those with an eGFR ?60 mL/min per 1.73 m²(16%).

The researchers described this similarity as "striking" because nocturnal hypoxia has previously been demonstrated to be associated with an increased loss of kidney function.

"The chronic hypoxia hypothesis suggests that chronic ischemic damage in the tubulointerstitium of the kidney is the final common pathway for the development of ESRD," explain Hanley et al.

"If such a process is already under way in patients with CKD, it is possible that ongoing nocturnal hypoxia will amplify the effect and accelerate the decline in kidney function," they add.

This means that identification and treatment of nocturnal hypoxia may provide a potential disease-modifying intervention that could delay or halt the progression of CKD to ESRD.

However, the researchers note that a history of snoring and unrefreshing sleep were equally common among the three patient groups, indicating that objective cardiopulmonary evaluation may be required to identify respiratory abnormalities.

Hanley and team also point out that by examining patients with the full spectrum of kidney function, rather than just patients with ESRD, the study addresses limitations of those conducted previously. It shows that "further studies are required to determine whether treatment of sleep apnea and nocturnal hypoxia improves these clinical outcomes in patients with CKD," they conclude.

Licensed from Medwire news with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.

...

WIXOM, MI--(Marketwire - June 11, 2012) - Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that the independent Data Safety Monitoring Board (DSMB), providing safety oversight for the Company's Phase III SFP-iron replacement clinical program, met and informed the company that it has carefully reviewed the cumulative safety data from the Phase III CRUISE studies and identified no safety concerns. The DSMB also recommended the continuation of the Phase III CRUISE studies with no modifications. SFP is a key product in the company's development pipeline and is currently in Phase III clinical trials for use as an iron replacement therapeutic in ESRD patients.

Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are pleased with this positive news resulting from the DSMB's third safety review of our ongoing CRUISE studies. We thank the DSMB members for their work. Their recommendation that the studies should proceed to completion as planned affirms our confidence in SFP's potential to deliver iron to dialysis patients in a safe, reliable manner."

Rockwell is conducting two identical Phase III clinical trials for SFP, called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study designed to demonstrate efficacy and safety with SFP-iron delivered via dialysate to adult CKD patients requiring hemodialysis. Each study will treat 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. The primary efficacy end-point for both studies is the mean change in hemoglobin from baseline.

About Rockwell Medical:

Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. Rockwell's lead, late-stage investigational drug for iron therapy treatment is called SFP (soluble ferric pyrophosphate). SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. market, and $1B global market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism addresses a $350M U.S. market. 

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval. 

Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and SFP following FDA approval. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical's SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

...

On December 31, 2007 while addressing the nation, the President of the Republic, Paul Biya said "...I intend to instruct the government to provide provincial hospitals that do not yet have any with dialysis equipment and scanners to relieve patients who are obliged to undertake long and tiresome journeys..."

This statement was re-echoed by the Minister of Public Health, André Mama Fouda, last Friday June 8 as he officially inaugurated the Yaounde Teaching Hospital haemodialysis centre which was renovated and equipped by the Japan Tokushukai Medical Corporation.

The Minister of Public Health said the event reveals one of the concrete realisation projects of the Head of State and marks another fruitful page in the relationship between Japan and Cameroon. The centre brings the number of Haemodialysis centres in the country to seven. The Minister used the occasion to announce that by September this year, there is hope to open the Bertoua and Ebolowa dialysis centres.

In the presence of the Japanese Ambassador to Cameroon and Cameroon's Ambassador to Japan, André Mama Fouda expressed gratitude to the government of Japan through the Tokushukai Medical Corporation for renovating the centre which consists of 10 modern dialyses machine, with a capacity of 70 to 80 patients and a water treatment station with two coal filters, among others. The government of Cameroon, on its part, rehabilitated the premises of the centre and also purchased some 7,058 dialyses kits that will help take care of patients for the next 12 months. The centre which was opened two days before its initial inauguration date had already admitted some 30 patients with acute kidney problems.

The Tokushukai Group has also promised to train some Cameroonian medical and technical personnel who will work alongside with Japanese staff at the centre. The dialysis centre offers a wide range of haemodialysis facilities for hospitalised patients and outpatients with chronic or acute renal failure requiring dialysis treatment. The centre also caters for patients in Intensive Care Units and those who are critically ill and suffering from acute renal failure.

On behalf of the Tokushukai Medical Corporation, Katsuyuki Noso said the ideal of Tokushukai Group is that patients can live their lives with confidence. Noso noted, "Tokunshukai's ideal is a society where everyone has access to optimum medical care whenever it is needed. Inspired by the mission of realising this ideal and putting ourselves in the patient's shoes, we devote all our efforts towards regional expansion and improvement in the service to the entire population".

...

Lindsey Duquette’s new kidney — a gift from her father — celebrated its one week anniversary Monday. Though she suffered a complication over the weekend, Lindsey’s hope is that it will celebrate many more weeks and years in the future — and that she will never be tethered to a dialysis machine again, as she was for 14 hours a day for the previous year.

“It’s functioning very well, and the doctors are pleased with that,” said Jim Duquette, the former Mets’ GM and Orioles’ executive, who donated the kidney to 10-year-old Lindsey in a transplant operation at Johns Hopkins Hospital in Baltimore last Monday.

Lindsey Duquette suffers from Focal Segmental Glomerulosclerosis (FSGS) — a serious kidney disorder with no known cure. The condition, which Lindsey has battled since she was 2½, necessitated the removal of her own kidneys one year ago. Her father was deemed the best match to provide her with a new one.

Lindsey, a 60-pound fifth grader who has had some 150 hospital admissions in her life, had a setback Saturday night, when doctors discovered a clot in her ureter, the narrow duct that carries urine from the kidney to the bladder. In a surgery Sunday, a small hole was poked into her kidney, allowing for a tube to be attached and her urine to flow into a bag by her side.

Once the clot resolves itself, Lindsey, who has nicknamed her new kidney Raven after the NFL football team, will have the bypass tube removed. Lindsey is expected to return home as early as the end of this week. In the meantime, Lindsey’s spirits have been boosted by the surprise gift from M&T Bank — an autographed Ray Rice football — and by the removal last Tuesday morning of her dialysis catheter.

The greatest concern with transplants for FSGS patients is that the disease will attack the new kidney. So far there are no signs of that happening. “The farther out we get from the transplant, the better the percentages that (the disease) will not recur,” said Pam Duquette, Lindsey’s mother

...