From The Almanac, Palo Alto, CA
A health scare, then a new restaurant
Two months after getting a kidney transplant she was never supposed to survive, Maria Neal opened her first restaurant.
It might sound like a recipe for chaos or, at the very least, excessive stress for someone recovering from a serious surgery. But for Neal, a 36-year-old mother of four from Peru, it was a change that she says has saved her life.
Neal, who lives in Menlo Park, opened Caffe Machiavello in the ground floor of Park Plaza Apartments at 195 Page Mill Road in Palo Alto in early August. The idea for the restaurant was born three years ago, when Neal, who was born with polycystic kidney disease, fell and harmed her kidneys. Her nephrologist told her she had a 14 percent chance of making it to her kidney transplant surgery -- not to survive the surgery, but simply to the day of, she said. She prepared for the worst.
"I had accepted that I was going to die," she said.
But survive she did, with a new kidney from her mother and a new outlook on what's most important to her. She left her job as a real estate agent to spend more time with her three sons and daughter, 16, 14, 8 and 6 years old.
Post-surgery, however, Neal's diet became extremely restricted and eating out with her children became near-impossible. Things were "chaotic," she said.
"I spent the last few years searching for stability ... to leave my kids something behind that they can actually remember mommy by, and for them to know that I was not going to just disappear," Neal said, sitting at a table inside Caffe Machiavello on a recent afternoon. "So I decided to build this restaurant."
Neal was encouraged by a mentor, an older local restaurant owner who had survived cancer twice. (He did not wish to be named.) He is like a father figure for Neal, who lost her father to the same kidney disease when she was a teenager.
He "pushed me to see life in a different way and to not believe what the doctors say necessarily," Neal said, "but to fight."
At Caffe Machiavello (Neal's maiden name), there is a high emphasis on quality of ingredients, largely due to the owner's dietary restrictions. In Neal's words, she doesn't use anything "that I can't pronounce." The bread for sandwiches, the pizza dough and the complimentary cookies brought to every table are all made in house. The kitchen uses a 50-year-old family recipe for the bread, Neal said, and imports flour from Italy for the pizza. They serve thin-crusted, Roman-style pinsa pizza made from Italian flour, olive oil and water.
The kitchen also has to be impeccably clean. Neal's kidney medications lower her immune defenses, making her extremely susceptible to any kind of illness.
The menu is global, with bruschetta and pizza next to hamburgers and chicken wings. Peruvian dishes include lomo saltado, steak flambe with onions, tomatoes, cilantro and rice or quinoa; pollo a la brasa, rotisserie chicken seasoned by Neal nightly with spices and aji panca, a Peruvian red pepper; and a quinoa bowl with roasted rocoto, a spicy Peruvian pepper. A deli section sells packaged international foods like Italian salami and Mediterranean spreads.
The wide culinary range is purposeful, meant to serve large families with different tastes and customers with dietary restrictions. Customers who want the kitchen to make them something special only need to ask, Neal said.
It's also reflective of a diverse staff, whom Neal refers to as her "family." She said she plans to give employees a portion of the restaurant's profit as it grows.
"You have food from around the world and people cooking from around the world. That's kind of what we want. Under this one roof, you can feel a little piece of what America used to be -- a humongous, beautiful, happy melting pot," she said.
Her family helps out frequently. Her husband DJs on a patio during happy hour, while her oldest son works at the restaurant after school.
Running the large, airy restaurant, and all the ups and downs that come with it, has become a welcome respite for Neal.
"This is not allowing me to feel weak or sick. I have not been able to rest ever since I left the hospital," she said. "I think that it helps me a lot. I'm very happy and very energetic, something that I didn't have before."
PKD Research
From Healio, Nephrology News & Issues
Phase 2 data show bardoxolone improves kidney function in patients with CKD
Results from a phase 2 study of bardoxolone methyl in patients with either IgA nephropathy or chronic kidney disease-associated type 1 diabetes showed improvement in eGFR after 12 weeks of therapy, according to a press release from Reata Pharmaceuticals Inc.
Improved kidney function in both cohorts was the primary endpoint of the PHOENIX study, which was conducted by the biopharmaceutical company.
“With these data, bardoxolone has improved kidney function in multiple rare forms of CKD, including Alport syndrome, autosomal dominant polycystic kidney disease, IgA nephropathy and type 1 diabetic CKD,” said Reata’s chief medical officer Colin Meyer, MD, in a press release. “The absence of drug-related serious adverse events and the eGFR improvements observed in the rare forms of CKD that we have studied suggest that bardoxolone has the potential to become an effective therapy for multiple rare forms of CKD.”
In the program, patients received bardoxolone orally once a day for 12 weeks. The primary efficacy endpoint was change from baseline in eGFR after 12 weeks of treatment.
In the IgA nephropathy cohort, patients treated with bardoxolone experienced an increase in eGFR of 8 mL/min/1.73 m2 (n=26) at Week 12 compared to baseline. Reata collected historical eGFR data for 23 of these patients, which demonstrated their kidney function was declining at an average annual rate of 1.2 mL/min/1.73 m2prior to study entry, the company said. The observed improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately 6 years of average eGFR loss, Reata reported.
In the type 1 diabetes cohort, patients treated with bardoxolone experienced a significant increase in eGFR of 5.5 mL/min/1.73 m2 (n=28) at Week 12 compared to baseline. Historical eGFR data for 22 of these patients showed kidney function was declining at an average annual rate of 1.9 mL/min/1.73 m2 prior to study entry. The observed improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately 3 years of average eGFR loss, the company said.
No treatment-related serious adverse events were reported in either cohort, and the reported adverse events were generally mild to moderate in intensity, Reata reported.
Reata said in its press release that the FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension, and the European Commission has granted orphan designation to bardoxolone for the treatment of Alport syndrome. In addition to PHOENIX, bardoxolone is being studied in CARDINAL, a phase 3 study for the treatment of Alport syndrome; in CATALYST, a phase 3 study for the treatment of connective tissue disease-associated pulmonary arterial hypertension; and in AYAME, a phase 3 study for the treatment of diabetic kidney disease in Japan, the company said.
Disparities seen in access to preemptive transplant listing
The new Kidney Allocation System has not solved inequities that low-income and minority patients with kidney disease face when seeking the benefits of preemptive waitlisting for a transplant, Drexel University College of Medicine researchers reported in a study published in the Journal Clinical Transplantation.
Preemptive waitlisting allows patients with kidney disease to be listed for a kidney transplant before requiring dialysis.
“The goal of this study was to examine whether the new [Kidney Allocation System] KAS was associated with differences in pre-transplant dialysis durations for (deceased donor kidney transplant) recipients with and without preemptive waiting time,” wrote study lead author Meera Nair Harhay, MD, a nephrologist and associate professor of medicine at Drexel University College of Medicine, and colleagues. “We performed a retrospective pre-post cohort study to examine whether average pre-transplant dialysis durations differed among kidney transplant recipients before and after KAS implementation based on the recipient’s preemptive listing status and by race/ethnicity.”
Getting on a waitlist for a transplant – and avoiding dialysis – has for some time “been skewed toward patients with a higher socioeconomic status, access to better health insurance and primary care,” wrote Lauren Ingeno in a summary of the study for the newsletter Drexel Now. “Low-income and minority patients, by contrast, are disproportionately less likely to receive care for their disease early, and therefore spend much longer on dialysis.”
Harhay and colleagues performed a retrospective study of deceased donor kidney transplant (DDKT) recipients between Dec. 4, 2011 and Dec. 3, 2014, prior to the implementation of the KAS, and between Dec. 4, 2014 to Dec. 3, 2017, post-KAS. Among 65,385 DDKT recipients, “preemptively listed recipients (21%, n = 13,696) were more likely to be white (59% vs. 34%, P < 0.001) and have private insurance (64% vs. 30%, P < 0.001),” the authors wrote. “In the pre- and post-KAS periods, average adjusted pretransplant dialysis durations for preemptively listed recipients were [less than] 2 years in all racial groups. Compared to recipients who were listed after starting dialysis, preemptively listed recipients experienced 3.85 (95% Confidence Interval [CI] 3.71-3.99) and 4.53 (95% CI 4.32-4.74) fewer average years of pretransplant dialysis in the pre- and post-KAS periods, respectively (P < 0.001 for all comparisons).”
“You would expect that this new system would reshuffle the deck a bit and narrow this gap - so that someone who had been on dialysis for 2 or 3 years might get a kidney transplant before someone who has not started dialysis,” said Harhay in Drexel Now. “But we did not find that to be the case. The gap between those who were listed early and listed late is still quite wide.”
KAS also gives the highest-quality kidneys to those who have had the least years on dialysis, opening the door to further disparities based on the timing of waitlisting, Leone wrote.
“[This] study found that among kidney transplant recipients of all races and ethnicities, preemptive wait-listing continues to confer a large benefit with respect to minimizing pre-transplant dialysis duration compared to listing after dialysis under the new KAS,” Harhay and colleagues wrote. “Future studies should be directed at mitigating persistent drivers of disparate access to preemptive waitlisting.”
It might sound like a recipe for chaos or, at the very least, excessive stress for someone recovering from a serious surgery. But for Neal, a 36-year-old mother of four from Peru, it was a change that she says has saved her life.
Neal, who lives in Menlo Park, opened Caffe Machiavello in the ground floor of Park Plaza Apartments at 195 Page Mill Road in Palo Alto in early August. The idea for the restaurant was born three years ago, when Neal, who was born with polycystic kidney disease, fell and harmed her kidneys. Her nephrologist told her she had a 14 percent chance of making it to her kidney transplant surgery -- not to survive the surgery, but simply to the day of, she said. She prepared for the worst.
"I had accepted that I was going to die," she said.
But survive she did, with a new kidney from her mother and a new outlook on what's most important to her. She left her job as a real estate agent to spend more time with her three sons and daughter, 16, 14, 8 and 6 years old.
Post-surgery, however, Neal's diet became extremely restricted and eating out with her children became near-impossible. Things were "chaotic," she said.
"I spent the last few years searching for stability ... to leave my kids something behind that they can actually remember mommy by, and for them to know that I was not going to just disappear," Neal said, sitting at a table inside Caffe Machiavello on a recent afternoon. "So I decided to build this restaurant."
Neal was encouraged by a mentor, an older local restaurant owner who had survived cancer twice. (He did not wish to be named.) He is like a father figure for Neal, who lost her father to the same kidney disease when she was a teenager.
He "pushed me to see life in a different way and to not believe what the doctors say necessarily," Neal said, "but to fight."
At Caffe Machiavello (Neal's maiden name), there is a high emphasis on quality of ingredients, largely due to the owner's dietary restrictions. In Neal's words, she doesn't use anything "that I can't pronounce." The bread for sandwiches, the pizza dough and the complimentary cookies brought to every table are all made in house. The kitchen uses a 50-year-old family recipe for the bread, Neal said, and imports flour from Italy for the pizza. They serve thin-crusted, Roman-style pinsa pizza made from Italian flour, olive oil and water.
The kitchen also has to be impeccably clean. Neal's kidney medications lower her immune defenses, making her extremely susceptible to any kind of illness.
The menu is global, with bruschetta and pizza next to hamburgers and chicken wings. Peruvian dishes include lomo saltado, steak flambe with onions, tomatoes, cilantro and rice or quinoa; pollo a la brasa, rotisserie chicken seasoned by Neal nightly with spices and aji panca, a Peruvian red pepper; and a quinoa bowl with roasted rocoto, a spicy Peruvian pepper. A deli section sells packaged international foods like Italian salami and Mediterranean spreads.
The wide culinary range is purposeful, meant to serve large families with different tastes and customers with dietary restrictions. Customers who want the kitchen to make them something special only need to ask, Neal said.
It's also reflective of a diverse staff, whom Neal refers to as her "family." She said she plans to give employees a portion of the restaurant's profit as it grows.
"You have food from around the world and people cooking from around the world. That's kind of what we want. Under this one roof, you can feel a little piece of what America used to be -- a humongous, beautiful, happy melting pot," she said.
Her family helps out frequently. Her husband DJs on a patio during happy hour, while her oldest son works at the restaurant after school.
Running the large, airy restaurant, and all the ups and downs that come with it, has become a welcome respite for Neal.
"This is not allowing me to feel weak or sick. I have not been able to rest ever since I left the hospital," she said. "I think that it helps me a lot. I'm very happy and very energetic, something that I didn't have before."
PKD Research
From Healio, Nephrology News & Issues
Phase 2 data show bardoxolone improves kidney function in patients with CKD
Improved kidney function in both cohorts was the primary endpoint of the PHOENIX study, which was conducted by the biopharmaceutical company.
“With these data, bardoxolone has improved kidney function in multiple rare forms of CKD, including Alport syndrome, autosomal dominant polycystic kidney disease, IgA nephropathy and type 1 diabetic CKD,” said Reata’s chief medical officer Colin Meyer, MD, in a press release. “The absence of drug-related serious adverse events and the eGFR improvements observed in the rare forms of CKD that we have studied suggest that bardoxolone has the potential to become an effective therapy for multiple rare forms of CKD.”
In the program, patients received bardoxolone orally once a day for 12 weeks. The primary efficacy endpoint was change from baseline in eGFR after 12 weeks of treatment.
In the IgA nephropathy cohort, patients treated with bardoxolone experienced an increase in eGFR of 8 mL/min/1.73 m2 (n=26) at Week 12 compared to baseline. Reata collected historical eGFR data for 23 of these patients, which demonstrated their kidney function was declining at an average annual rate of 1.2 mL/min/1.73 m2prior to study entry, the company said. The observed improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately 6 years of average eGFR loss, Reata reported.
In the type 1 diabetes cohort, patients treated with bardoxolone experienced a significant increase in eGFR of 5.5 mL/min/1.73 m2 (n=28) at Week 12 compared to baseline. Historical eGFR data for 22 of these patients showed kidney function was declining at an average annual rate of 1.9 mL/min/1.73 m2 prior to study entry. The observed improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately 3 years of average eGFR loss, the company said.
No treatment-related serious adverse events were reported in either cohort, and the reported adverse events were generally mild to moderate in intensity, Reata reported.
Reata said in its press release that the FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension, and the European Commission has granted orphan designation to bardoxolone for the treatment of Alport syndrome. In addition to PHOENIX, bardoxolone is being studied in CARDINAL, a phase 3 study for the treatment of Alport syndrome; in CATALYST, a phase 3 study for the treatment of connective tissue disease-associated pulmonary arterial hypertension; and in AYAME, a phase 3 study for the treatment of diabetic kidney disease in Japan, the company said.
Kidney Transplant
From Healio, Nephrology News & Issues
The new Kidney Allocation System has not solved inequities that low-income and minority patients with kidney disease face when seeking the benefits of preemptive waitlisting for a transplant, Drexel University College of Medicine researchers reported in a study published in the Journal Clinical Transplantation.
Preemptive waitlisting allows patients with kidney disease to be listed for a kidney transplant before requiring dialysis.
“The goal of this study was to examine whether the new [Kidney Allocation System] KAS was associated with differences in pre-transplant dialysis durations for (deceased donor kidney transplant) recipients with and without preemptive waiting time,” wrote study lead author Meera Nair Harhay, MD, a nephrologist and associate professor of medicine at Drexel University College of Medicine, and colleagues. “We performed a retrospective pre-post cohort study to examine whether average pre-transplant dialysis durations differed among kidney transplant recipients before and after KAS implementation based on the recipient’s preemptive listing status and by race/ethnicity.”
Getting on a waitlist for a transplant – and avoiding dialysis – has for some time “been skewed toward patients with a higher socioeconomic status, access to better health insurance and primary care,” wrote Lauren Ingeno in a summary of the study for the newsletter Drexel Now. “Low-income and minority patients, by contrast, are disproportionately less likely to receive care for their disease early, and therefore spend much longer on dialysis.”
Harhay and colleagues performed a retrospective study of deceased donor kidney transplant (DDKT) recipients between Dec. 4, 2011 and Dec. 3, 2014, prior to the implementation of the KAS, and between Dec. 4, 2014 to Dec. 3, 2017, post-KAS. Among 65,385 DDKT recipients, “preemptively listed recipients (21%, n = 13,696) were more likely to be white (59% vs. 34%, P < 0.001) and have private insurance (64% vs. 30%, P < 0.001),” the authors wrote. “In the pre- and post-KAS periods, average adjusted pretransplant dialysis durations for preemptively listed recipients were [less than] 2 years in all racial groups. Compared to recipients who were listed after starting dialysis, preemptively listed recipients experienced 3.85 (95% Confidence Interval [CI] 3.71-3.99) and 4.53 (95% CI 4.32-4.74) fewer average years of pretransplant dialysis in the pre- and post-KAS periods, respectively (P < 0.001 for all comparisons).”
“You would expect that this new system would reshuffle the deck a bit and narrow this gap - so that someone who had been on dialysis for 2 or 3 years might get a kidney transplant before someone who has not started dialysis,” said Harhay in Drexel Now. “But we did not find that to be the case. The gap between those who were listed early and listed late is still quite wide.”
KAS also gives the highest-quality kidneys to those who have had the least years on dialysis, opening the door to further disparities based on the timing of waitlisting, Leone wrote.
“[This] study found that among kidney transplant recipients of all races and ethnicities, preemptive wait-listing continues to confer a large benefit with respect to minimizing pre-transplant dialysis duration compared to listing after dialysis under the new KAS,” Harhay and colleagues wrote. “Future studies should be directed at mitigating persistent drivers of disparate access to preemptive waitlisting.”
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