Drug – bio-affecting and body treating compositions – With corrosion inhibitor
Reexamination Certificate
2001-04-24
2003-05-06
Dees, Jose G. (Department: 1616)
Drug, bio-affecting and body treating compositions
With corrosion inhibitor
C514S557000, C514S054000, C514S263370, C424S085100, C424S600000
Reexamination Certificate
active
06558667
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method for treating a renal disease, and a pharmaceutical composition for treating a renal disease. More particularly, a method for ameliorating a chronic renal failure by a combination of a dialysis therapy and a spherical activated carbon administration, and a pharmaceutical composition for treating a chronic renal failure by a combination of a dialysis therapy and a spherical activated carbon administration.
2. Description of the Related Art
A normal kidney excretes waste materials, regulates an amount of humors (water content), provides an electrolyte balance, an acid-base equilibrium, and blood pressure, and produces hormones. A condition wherein the kidney is prevented from functioning normally, as above, and thus a homeostasis is not maintained, is called a renal failure. An acute renal failure is curable, whereas a chronic renal failure is an irreversible and progressively pathologic state. When a patient suffers a chronic renal failure, the renal functions are not recovered, and he or she will inevitably suffer from uremia. It is believed that it is impossible to heal or recover a chronic renal failure, but only to delay a worsening rate, or retard a presence of symptoms of uremia.
The functions of a kidney can be evaluated by one of several indexes, i.e., an excreting function, which is one of the most important functions. The index of the excreting function is, usually, an endogenous creatinine clearance (Ccr) that corresponds nearly to an amount of a glomerular filtration. Ccr indicates a renal excreting function for a creatinine that is a metabolite of a muscle, and can be regarded as a representative or standard value of the excreting function of a kidney. A normal value of Ccr is 70 to 130 mL/min.
A urine volume is also used as one of the parameters reflecting renal functions, because it generally is decreased with a decrease of renal functions (except for cases wherein a urine volume is temporarily increased when an abnormality in a filtrating function of a kidney is caused), and in particular, is remarkably decreased in an end-stage renal failure. A normal value of a urine volume is 1000 to 1500 mL/day.
The Ccr decreases with a progress of a chronic renal dysfunction, such as chronic glomerulonephritis, diabetic nephropathy, or nephrosclerosis. In general, a state having a Ccr value of 30 mL/min or less is called a chronic renal failure. After a pathologic state reaches such a chronic renal failure, a renal function, i.e., a residual renal function, cannot be recovered, and ultimately the pathologic state reaches a state of uremia. A serious state having a decreased Ccr value of 10 mL/min or less is called uremia. After a pathologic state reaches uremia, a urine volume falls generally to 1000 mL/day or less. As above, in a pathologic state of a chronic renal failure, the Ccr and the urine volume gradually decrease with a deterioration of a residual renal function, and when the pathologic state is worsened, the Ccr and the urine volume cannot be recovered.
A patient having an insufficient function of excretion with a progress of a chronic renal failure is introduced to a dialysis therapy. The stage at which the dialysis therapy is introduced varies with a condition of a patient, but in general, the dialysis therapy is introduced when a Ccr value becomes 10 mL/min or less or a creatinine value becomes 8 mg/dL or more. The dialysis therapy is carried out for an end-stage patient having a progressive chronic renal failure, to remove urine toxins, water, or salt, adjust an acid-base balance inclining to a metabolic acidosis, and maintain homeostasis in a body. The dialysis therapy is classified broadly into two major classes, that is, a hemodialysis (HD) and a peritoneal dialysis (PD).
In the hemodialysis, blood is brought into contact with a dialysis solution via a semipermeable membrane such as a cellophane membrane installed in an extracorporeal dialyzer. The hemodialysis must be carried out in a hospital or the like where the dialyzer is located. Therefore, the patient must periodically and frequently visit a hospital, and thus a quality of life, QOL, is considerably impaired.
In the peritoneal dialysis, on the other hand, a peritoneum in a patient's body is used as a dialysis membrane. More particularly, the peritoneum is composed of a peritoneum parietale covering an abdominal wall and a peritoneum viscerale covering various internal organs, and functions as a semipermeable membrane, and thus can be utilized as a dialysis membrane. The peritoneal dialysis does not require frequent visits to a hospital, and is preferable in comparison with the hemodialysis in view of the QOL.
However, it is known that the introduction of the hemodialysis or peritoneal dialysis leads to a rapid deterioration of a residual renal function. It is said that the residual renal function can be generally maintained for a long period of time by the peritoneal dialysis, in comparison with the hemodialysis. However, for example, Nephrol Dial. Transplant, (1999) 14: 1224-1228 discloses that a renal function was decreased by 57% in a patient treated by an automated peritoneal dialysis (APD), and by 24% in a patient treated by a continuous ambulatory peritoneal dialysis (CAPD).
Therefore, there arose an urgent need for a means of retarding a deterioration of a residual renal function in a patient suffering from a chronic renal failure and to whom a dialysis therapy is introduced.
An oral adsorbent that can be orally administered, and enables a treat of a dysfunction of a kidney is known. Specifically, U.S. Pat. No. 4,681,764 discloses an adsorbent composed of a porous spherical carbonaceous material having specific functional groups, having a high level of safety for and stability in a body, exhibiting a useful selective adsorbability, that is, exhibiting an excellent adsorbability of toxic substances in the presence of intestinal bile acids while removing very little of the internal useful ingredients such as digesting enzymes, and having little side effects such as constipation. The adsorbent is widely and clinically used for a renal dysfunction patient having more than a certain level of a renal function, i.e., a patient in a conserving stage prior to an introduction of a dialysis therapy.
Attempts to combine the oral adsorbent and the dialysis therapy are reported. For example, two clinical cases are reported in S. Takara, et al. “Jin-To-Toseki (Kidney and Dialysis)” Vol. 20, No. 6,1986, 81-85. In the first case, an oral adsorbent was administered to a patient in a conserving stage. When the patient's conditions became worse, the oral adsorbent was discontinued, and a peritoneal dialysis was instituted under conditions of a blood urea nitrogen (BUN) of 120 mg/dL, a creatinine value (Cr value) of 13.2 mg/dL, and a urine volume of 1500 mL/day. Further, when the patient's conditions became severe, a hemodialysis was introduced and an administration of the oral adsorbent at a urine volume of 300 to 200 mL/day was made while continuing the peritoneal dialysis. In the second case, the oral adsorbent was administered to a patient in a conserving stage. A hemodialysis was introduced to the patient under conditions of a BUN of 140 mg/dL and a Cr value of 7.8 mg/dL while increasing a dose of the oral adsorbent. Then, the hemodialysis was substituted with a peritoneal dialysis under the condition of a urine volume of 100 mL/day. Takara, et al., disclose that clinical symptoms were ameliorated in each case. However, clinical data disclosed in Takara, et al., show that, when a combination of the peritoneal dialysis and the oral adsorbent was started, the urine volume was decreased to 300 to 200 mL/day (the first case) and to 100 mL/day (the second case), and then, in the first case, the urine volume was decreased to 0 mL/day after about 10 months from the beginning of the combination of the peritoneal dialysis and the oral adsorbent, and the hemodialysis, and in the second case, the urine volume
Dees Jos,e G.
DeWitty Robert M
Kureha Chemical Industry Co. Ltd.
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