A Phase 2 interventional study of GCS-100 in Chronic Kidney Disease, sponsored by La Jolla Pharmaceutical Company. Completed at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-26.
Sponsored by La Jolla Pharmaceutical Company · Phase 2, Interventional, and Treatment
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Among 988 studies in Renal Insufficiency, Chronic with a site in United States — 171 open to participants now, 218 under way, 25 of them phase 3. Renal Insufficiency, Chronic · United States.
Among the 988 studies in Renal Insufficiency, Chronic with a site in United States, this one is the 371st largest by enrollment of the 819 interventional ones that give a count, is one of 39 that started in 2014, is one of 156 in phase 2, and was the 342nd registered.
3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →171 of the 988 studies in Renal Insufficiency, Chronic with a site in United States are open now. Recruiting first, the newest first:
University of Chicago · Sites in United States
Ages 18–70
Indiana University · Sites in United States
Ages 40–70
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
University of Minnesota · Sites in United States
Ages 30–75
United Therapeutics · Sites in United States
Ages 40–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
988 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 109 · Phase 2 185 · Phase 3 160 · Phase 4 81
First in 1988; this study’s year is marked. 39 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 92 is above the median of 73 across 2,162 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 72 across the 819 interventional studies, 125 across the 165 observational. Of the 696 that completed or were terminated, 344 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
372 of 988 have an industry lead sponsor. The 10 most frequent:
La Jolla Pharmaceutical Company is the lead sponsor of 18 studies on the registry; none are open to participants now.
La Jolla Pharmaceutical Company has 4 studies filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
73 of the studies in Renal Insufficiency, Chronic with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03565913Phase 3University of Texas Southwestern Medical CenterPotential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V | 2026-12-01 |
| NCT06531824Phase 3Boehringer IngelheimEASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | 2026-12-31 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT07107945Phase 3Boehringer IngelheimA Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) | 2027-04-16 |
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
Add all 73 to your calendar (.ics) → With an account.
Among the 988 studies in Renal Insufficiency, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.
Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney. GCS-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating patients with CKD.
Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage 3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety events, may be asked to participate in this study to test the safety of prolonged administration of study drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has clinical laboratory results of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low dose of GCS-100
Drug: GCS-100
GCS-100 High dose
Drug: GCS-100
1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.
Evaluation of Safety
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
Time frame: Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period.
The record gives a start of Jan 2014, a primary completion of May 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GCS-100
Renal Insufficiency, Chronic →
La Jolla Pharmaceutical Company